FM/CFS/ME RESOURCES - JANUARY ALERTS, NEWS & PRODUCT RECALLS
 



 




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 JANUARY ALERTS, NEWS & PRODUCT RECALLS

This section contains medical alerts, medical news and product recalls for the following countries:

Medical News
  • Australia
  • Canada
  • Ireland
  • New Zealand
  • United Kingdom
  • United States
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USDA Recall
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  DATE  ALERTS, NEWS, RECALLS
Jan. 31, '10
Jan. 29, '10
Jan. 28, '10

Jan. 27, '10

Jan. 26, '10
Jan. 23, '10
Jan. 22, '10
Jan. 21, '10
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Jan. 18, '10
United States
Jan. 15, '10 Australia
United States
Jan. 14, '10 United States
Jan. 13, '10 United States
Jan. 12, '10 United States
Jan. 11, '10 United States
Jan. 9, '10 United States
Jan. 7, '10 United States
Jan. 6, '10 Australia
United States
Jan. 5, '10 United Kingdom
Jan. 4, '10 Ireland
United States
Jan. 3, '10 Australia
Jan. 1, '10 United States

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Jan. 31, 2010

Expanded Recall Of Italian Sausage Products

This recall release is being reissued to expand the January 23 recall to include approximately 17,235 pounds of Italian sausage products.

Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., is expanding its January 23 recall to include approximately 17,235 pounds of ready-to-eat (RTE) varieties of Italian sausage products, including salami/salame, that may be contaminated with Salmonella, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The recall is being expanded as a result of a confirmed finding of Salmonella in an unopened salami product reported by the Illinois Department of Public Health. The product was sampled during the course of an ongoing investigation of a multi-state outbreak of Salmonella serotype Montevideo illnesses. The product tested was not included in the previous recall (FSIS Recall 006-2010) issued January 23, but is similar to products bought by customers who later became sick in the Montevideo investigation. Product subject to the expanded recall may have been cross-contaminated with black pepper before it was packed. The company believes that black pepper is a possible source of Salmonella contamination.

Further testing is ongoing at a state health partner laboratory, and may determine if the product contained the Salmonella Montevideo strain associated with the multi-state outbreak. The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), FSIS, state health and agriculture departments, and Daniele International are cooperating in this investigation. The CDC has posted information about the multi-state outbreak on its website (http://www.cdc.gov/salmonella) but the investigation is ongoing, and has not yet definitively identified a food vehicle(s).

FSIS is continuing to work with the CDC, FDA, affected state public health partners, and the company on the investigation and will update the public on the progress of this investigation as information becomes available.

The products subject to recall include:

  • Packages of "DANIELE HOT SOPRESSATA CALABRESE," produced on 11/7/09, 12/16/09 and 12/18/09.

  • Packages of "DANIELE SOPRESSATA CALABRESE," produced on 12/16/09 and 12/18/09.

  • Packages of "BOAR'S HEAD BRAND HOT SOPRESSATA CALABRESE," produced on 11/28/09, 12/9/09 and 12/14/09.

Each package bears a label with establishment number "EST. 54" inside the USDA mark of inspection and weighs approximately 3 to 3.5 pounds. These products were distributed to retail establishments nationwide. When available, the retail distribution list(s) will be posted on FSIS' website.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers (including restaurants) of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Media and consumer questions regarding the recall should be directed to the company’s Hotline at (888) 345-4160 and its PR contact, Levick at (202) 973-1335.

Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. Salmonella infections can be life-threatening, especially to those with weak immune systems, such as infants, the elderly, and persons with HIV infection or undergoing chemotherapy. The most common manifestations of salmonellosis are diarrhea, abdominal cramps, and fever within eight to 72 hours. Additional symptoms may be chills, headache, nausea and vomiting that can last up to seven days.

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Jan. 29, 2010

Natural Health Products containing Glucomannan May Cause Serious Choking

Health Canada is advising Canadians that natural health products containing the ingredient glucomannan in tablet, capsule or powder form, which are currently on the Canadian market, have a potential for harm if taken without at least 8 ounces of water or other fluid. The risk to Canadians includes choking and/or blockage of the throat, esophagus or intestine, according to international adverse reaction case reports. It is also important to note that these products should NOT be taken immediately before going to bed.

Health Canada has authorized some products containing glucomannan for the purposes of appetite reduction, weight management, treatment of constipation, management of cholesterol levels.

This advisory comes in light of Health Canada's action to work with manufacturers and distributors of products containing glucomannan to help ensure that these products are labelled appropriately with complete directions of use and cautionary statements. Should new safety information become available, Health Canada will provide an update to Canadians. The required label information is as follows:

Directions for Use

Take (or mix) this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product with insufficient liquid may result in choking and/or blockage of the throat, esophagus or intestine. Do not take immediately before going to bed.

Cautions and Warnings

Consult a healthcare practitioner prior to use if you are pregnant or breastfeeding. Consult a healthcare practitioner prior to use if you have diabetes.

Contraindication

Do not use this product if you have difficulty swallowing.

Known Adverse Reaction

If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Consumers should consult with their health care practitioner if they still have any questions or concerns. Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

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Jan. 29, 2010

Unauthorized Natural Choice Health Products Found on the Canadian Market

Health Canada is advising consumers not to use any unauthorized health products sold under the brand names:

  • Natural Choice Vitamin B-17
  • Natural Choice Kava Kava
  • Natural Choice Lithium Orotate

These unauthorized health products have a similar identifying image on their label (below). Consumers should note that the above-mentioned products may also be available under the brand names:

  • Life Choice
  • Doctor's Choice
  • Your Choice
  • Healthy Choice

As these products have been marketed under a variety of brand names.

Health Canada previously issued a Public Warning on two other Life Choice products, Life Choice Ephedrine 30mg and Life Choice Kava Kava, on August 21, 2008, and an Advisory on twenty-two unapproved products under these brand names on September 3, 2008.

The unauthorized Natural Choice Vitamin B-17, according to what is listed on the product label, contains amygdalin which is a compound derived from bitter apricot kernels that has the potential to release cyanide when ingested by humans. Small amounts of cyanide are detoxified by the human body but low to moderate amounts ingested chronically can lead to serious adverse health consequences and high doses can be lethal.

The unauthorized Natural Choice Kava Kava, according to what is listed on the product label, contains kava lactones. Health Canada and several foreign regulatory agencies have received reports associating the use of kava with serious liver dysfunction. As such, Kava is on the Restricted Substances list in the Natural Health Products Compliance Guide (Health Canada 2007a).

The unauthorized Natural Choice Lithium Orotate is being sold without a prescription although ingredients listed on the product label would require the product to be sold to patients by prescription. There are risks with taking these drugs without supervision by a health care practitioner. You may be misdiagnosed, the treatment might not be appropriate to treat your illness and you may miss the opportunity to obtain appropriate treatment. You may also put yourself at risk for drug interactions, or harmful side effects.

The above products are not authorized for sale in Canada . Consumers are reminded that health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises retailers to remove this product from their shelves.

Canadians who have used these brands of products and are concerned about their health should consult a health care practitioner. Consumers who have purchased these products should return them to the place of purchase.

Health Canada also advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find these brands of products for sale in Canada.

Consumers requiring more information about this warning can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

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Jan. 28, 2010

Marevan (warfarin) Tablets Recalled

The Problem
A manufacturing problem could result in some tablets containing a higher dose than listed. Consuming a tablet with a higher than usual dose may result in abnormal bruising and/or bleeding, vomiting blood or with the appearance of coffee grounds, blood in the urine or stool, or black tarry stools.

Details
Marevan (warfarin) blue 3mg tablets supplied after 23 November 2009. Marevan is an anticoagulant treatment widely used to prevent blood clots.

What To Do
You should not suddenly stop taking this medicine. However, you should have the tablets replaced and seek advice as soon as possible. Tablets can be exchanged at your pharmacy free-of-charge. Contact the doctor or clinic that prescribed the medicine for advice on whether further monitoring may be required. If you have suffered any ill effects you should see your doctor immediately.

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Jan. 28, 2010

Class 3 Drug Alert for IntronA

Schering-Plough Ltd

IntronA 18 million IU solution for injection EU/1/99/127/031-033
IntronA 30 million IU solution for injection EU/1/99/127/034-036
IntronA 60 million IU solution for injection EU/1/99/127/037-039

(Recombinant interferon alfa-2b)

Presentation Batch # Expiry Date First Distributed
IntronA 18MIU Multidose Pen 9IOL10504 Oct 2010 14 Jul 2009
IntronA 18MIU Multidose Pen 9IOL10609 Nov 2010 14 Sep 2009
IntronA 30MIU Multidose Pen 9IOK40308 Oct 2010 01 Oct 2009
IntronA 30MIU Multidose Pen 9IOK40328 Oct 2010 22 Dec 2009
IntronA 60MIU Multidose Pen 9IOM70212 Sep 2010 01 Oct 2009
IntronA 60MIU Multidose Pen 9IOM70316 Sep 2010 23 Nov 2009

Schering-Plough Ltd is recalling the above batches, which have an expiry date of 18 months, as a precautionary measure because the stability of the products after 15 months cannot be assured. All new batches are labelled with a 15 month expiry date and are being supplied through normal wholesaler channels.

Pharmacists are asked to quarantine any remaining stocks from these batches. Schering-Plough Ltd is writing to wholesalers and hospital pharmacies that may have received these batches and is providing them with instructions on how to return any stock. If you have stock from these batches, and have not heard from Schering-Plough Ltd within five days from receipt of this letter, please either telephone or email Customer Care, tel 01707 36375; email UKCustomercare@spcorp.com.

For Medical Information enquiries, please telephone Schering-Plough Ltd on 01707 363636

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Jan. 28, 2010

Instant Noodle Products Recalled

Well Luck Co., Inc., a Jersey City, N.J., establishment, is recalling approximately 50,000 pounds of instant noodle products that were ineligible for import to the U.S., the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

Well Luck Co., Inc., is recalling the instant noodle products because they do not meet product inspection or exemption requirements for poultry, beef, and pork. The foreign inspection system of the country where the beef, poultry, and pork ingredients originated, China, has not been deemed to be equivalent as required by federal regulations.

The following product is subject to recall:

  • Cases of 12 packages containing five 110g-packs of "JIN MAI LANG Instant Noodles, Stew Beef Flavour." Each package bears a use by date of 10/5/2010. Each case bears a case code of 42894.

  • Cases of 12 packages containing five 112g-packs of "JIN MAI LANG Instant Noodles, Stew Pork Flavour." Each package bears a use by date of 10/8/2010. Each case bears a case code of 42895.

  • Cases of 12 packages containing five 110g-packs of "JIN MAI LANG Instant Noodles, Spicy Beef Flavour." Each package bears a use by date of 10/8/2010. Each case bears a case code of 42896.

  • Cases of 12 packages containing five 110g-packs of "JIN MAI LANG Instant Noodles, Spicy Beef Flavour." Each package bears a use by date of 10/8/2010. Each case bears a case code of 42896.

  • Cases of 12 packages containing five 110g-packs of "JIN MAI LANG Instant Noodles, Spicy Hot Beef Flavour." Each package bears a use by date of 10/8/2010. Each case bears a case code of 42897.

  • Cases containing 18 143g-packs of "JIN MAI LANG Instant Noodles, Korean Style, Stew Beef Flavour." Each pack bears a use by date of 10/9/2010. Each case bears a case code of 42903.

  • Cases containing 18 143g-packs of "JIN MAI LANG Instant Noodles, Korean Style, Stew Pork Flavour." Each pack bears a use by date of 10/9/2010. Each case bears a case code of 42904.

  • Cases containing 18 141g-packs of "JIN MAI LANG Instant Noodles, Korean Style, Spicy Beef Flavour." Each pack bears a use by date of 10/9/2010. Each case bears a case code of 42905.

  • Cases containing 18 140g-packs of "JIN MAI LANG Instant Noodles, Korean Style, Mushroom Chicken Flavour." Each pack bears a use by date of 10/12/2010. Each case bears a case code of 42936.

  • Cases containing 12 116g-bowls of "JIN MAI LANG Instant Noodles, Stew Beef Flavour." Each pack bears a use by date of 10/9/2010. Each case bears a case code of 42920.

  • Cases containing 12 116g-bowls of "JIN MAI LANG Instant Noodles, Stew Pork Flavour." Each pack bears a use by date of 9/28/2010. Each case bears a case code of 42921.

  • Cases containing 12 119g-bowls of "JIN MAI LANG Instant Noodles, Stew Pork Flavour." Each pack bears a use by date of 10/9/2010. Each case bears a case code of 42922.

  • Cases containing 12 110g-bowls of "JIN MAI LANG Instant Noodles, Mushroom Chicken Flavour." Each pack bears a use by date of 10/9/2010. Each case bears a case code of 42919.

  • Cases containing 12 83g-cups of "JIN MAI LANG Instant Noodles, Stew Beef Flavour." Each pack bears a use by date of 10/10/2010. Each case bears a case code of 42934. Cases containing 12 86g-cups of "JIN MAI LANG Instant Noodles, Stew Pork Flavour." Each pack bears a use by date of 10/10/2010. Each case bears a case code of 42933.

  • Cases containing 12 83g-cups of "JIN MAI LANG Instant Noodles, Spicy Pork Flavour." Each pack bears a use by date of 10/10/2010. Each case bears a case code of 42932.

The problem was discovered after FSIS identified the products in the marketplace. The instant noodle products were distributed to retail establishments nationwide. FSIS has received no reports of illness as a result of consuming these products.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumers and media with questions about the recall should contact company coordinator, Shany Chang, at (201) 434-1177 ext. 141.

FSIS works with other federal agencies to ensure the safety of imported meat, poultry and processed egg products. The Animal and Plant Health Inspection Service issues import permits based on animal health considerations, specific to a country or region. Customs and Border Protection provides oversight of all products entering the United States.

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Jan. 27, 2010

Important Information Concerning Medication for Parkinson's Disease

Health Canada is aware that two Canadian companies that manufacture and/or distribute medications for Parkinson's Disease have posted information on their websites concerning the availability of some of the drugs they manufacture and/or distribute.

Bristol Myers Squibb Canada, the Canadian distributor of Sinemet CR (200/50) has information on its website: www.bmscanada.ca or call the Bristol Myers Squibb Canada Information Line at 1-800-267-0005.

Apotex Inc. has information on its generic product, Apo-Levocarb CR (200/50) on its website or call 1-877-427-6839.

Patients who are currently using Apo-Levocarb CR (200/50) or Sinemet CR (200/50) and have concerns about the supply of their medication may want to check the information provided by these companies or call the companies. Patients may also consult their health care professional in order to explore alternative treatments if they are unable to maintain an uninterrupted supply of their medication.

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Jan. 27, 2010

Retail List of Recalled Sausage Products

FSIS has reason to believe that the following retail location(s) received ready-to-eat varieties of Italian sausage products, including salami/salame, that have been recalled by Daniele International Inc.

This list may not include all retail locations that have received the recalled product or may include retail locations that did not actually receive the recalled product. Therefore, it is important that you use the product-specific identification information, available at Daniele International Recalling Italian Sausage Products, in addition to this list of retail stores, to check meat or poultry products in your possession to see if they have been recalled.

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Jan. 27, 2010

Swivel Plug Extension Leads Recalled

Product Description
Mains extension cord sets of lengths - 3m, 5m 7m and 10m with plug approval number SGSEA/090440.

Identifying Features
SPL3, SPL5, SPL7 and SPL10 on the packaging and "SESP2 - SGSEA/090440" markings engraved on the affected extension lead plug face.

Hazards:
Live parts may become exposed leading to a possibility of electric shock.

Defects:
There is a risk that the plug top cover may separate from the plug pins on excessive force thus exposing the live parts.

Dates Available For Sale:
* November 2009 - January 2010

Where Product Was Sold:
* National

Traders Who Sold Product:
Bunnings, Kmart, Mitre10 and in limited quantities to other small retailers

Supplier:
Arlec Australia Pty Ltd

Comments:
If the plug face has Approval No. SGSEA/090440, customers must immediately stop using the identified extension leads. For a replacement or refund, or if you are unsure of the model number of the extension lead, please contact Arlec Customer Service for assistance on: Phone 03 9727 8860, Fax 1300 360 650 (toll free), www.arlec.com.au

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Jan. 26, 2010

FDA Announces Class I Recall of Certain Infusion Set Needles

The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.

Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.

Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles "cored" in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate.

There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with "07," "08," "09," and one of the following product codes or catalog numbers:

Exel/Exelint Huber Needles Product Codes/Catalog Numbers
  • 26901
  • 26902
  • 26904
  • 26906
  • 26907
  • 26908
  • 26909
  • 26911
  • 26921
  • 26922
  • 26923
  • 26924
  • 26925

Exel/Exelint Huber Infusion Sets Product Codes/Catalog Numbers With/Injection Site:
  • 27940R
  • 27941R
  • 27944R
  • 27945R
  • 27946R
  • 27948R
  • 27949R
  • 27950R

Without/Injection Site Product Codes/Catalog Numbers:

  • 27954R
  • 27955R
  • 27958R
  • 27959R


Exel/Exelint "SecureTouch +" Safety Huber Sets Product Codes/Catalog Numbers:

  • 37854S
  • 37855S
  • 37858S

Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation. Direct all questions concerning this recall to:

Attn: Armand Hamid
EXEL International
5408 West Centinela Ave
Los Angeles, Calif. 90045-1504
Tel. 800-940-3935
Fax 800-308-5048
E-mail: info@exelint.com

Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be non-coring), the agency conducted it own laboratory testing of Huber needles from multiple manufacturers. This testing showed that certain Huber needles produced cores when inserted into ports. However, at this time only needles manufactured by Nipro have shown a high frequency for coring. The agency is continuing its investigation and will update the public if there are new developments.

At this time, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from Huber needle coring.The agency received only reports of port leakage. However, because it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, there may be under-reporting of events.

The agency has issued a letter to manufacturers of other Huber needles to address design and manufacturing concerns.

"The agency's laboratory work helped determine the coring problem, and we will continue to work with manufacturers to address coring issues as quickly and thoroughly as possible," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

The FDA continues to work closely with all 20 manufacturers of Huber needles to understand the potential causes for coring and identify corrective measures. While a more thorough investigation of this situation continues, the FDA recommends that health care professionals consider taking the following precautions, which will be posted on the FDA's Web site, when accessing implanted ports with Huber needles:

  • Avoid flushing the syringe when initially confirming needles patency upon accessing the port. If the needle has cored the port, flushing may introduce the core into the patient's body, and could lead to serious adverse events.

  • When possible, upon accessing the port, consider aspirating a small amount of blood from the port after septum puncture, then discard the syringe with its contents. This step may recapture the silicone sliver. If the needle becomes clogged when attempting to aspirate, remove the needle, discard it and select a new one.

  • Watch for signs and/or symptoms that may indicate damage to the port's septum, such as medication leakage resulting in inadequate therapy delivery, along with tissue, nerve and/or muscle damage; and redness of the surrounding area.

  • Patients should continue to follow their doctor's recommendations for receiving treatment.

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Jan. 26, 2010

FDA Approves Morphine Sulfate Oral Solution for Acute and Chronic Pain

The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

This is the only FDA approved morphine sulfate oral solution available at this concentration. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA approved until now.

Today's action is part of the FDA's unapproved drugs initiative. As part of this program, the FDA has worked with the manufacturer of the now-approved product, Roxane Laboratories, to ensure that there is enough drug available for patients. The FDA will also be working with patient organizations and prescribers so that they are aware that an approved product is available, and can notify the FDA if there are any problems with availability.

"An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards," said Douglas Throckmorton, M.D., deputy director for the FDA's Center for Drug Evaluation and Research. "Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law."

One benefit of the FDA approval process is a requirement for manufacturers to provide sufficient information on how to safely prescribe and use a drug. Manufacturers may also have to establish additional safety measures to manage unique risks of a medicine. For this formulation of morphine, the manufacturer had to develop a safety program prior to approval to address the known risks of morphine misuse, abuse and overdose.

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Jan. 23, 2010

Sibutramine: Suspension of Marketing Authorisation - Risks Outweigh Benefits

The European Medicines Agency (EMA) has completed a review of the obesity medicine sibutramine (Reductil) on the basis of new safety information from a large clinical trial, the Sibutramine Cardiovascular OUTcomes (SCOUT) study. The review has found that the cardiovascular risks of sibutramine outweigh its benefits. The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended suspension of the marketing authorisation for this medicine across the European Union.

Further information is available on the EMA website.

Advice for healthcare professionals and patients

  • Doctors should not issue any new prescriptions for sibutramine and should review the treatment of those who are currently taking this medicine.

  • Pharmacists should not dispense any prescriptions for sibutramine and should advise patients to make an appointment to see their doctor at the next convenient time.

  • Patients who are currently being treated with sibutramine should be advised to schedule an appointment at the next convenient time with their doctor to discuss alternative measures to lose weight, including use of diet and exercise regimes. Patients may stop treatment before their appointment if they wish.

A Direct Healthcare Professional Communication and a series of questions and answers is available for download below.

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Jan. 23, 2010

Daniele International Recalling Italian Sausage Products

Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., is recalling approximately 1,240,000 pounds of ready-to-eat (RTE) varieties of Italian sausage products, including salami/salame, in commerce and potentially available to customers in retail locations because they may be contaminated with Salmonella, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

FSIS became aware of the problem during the course of an ongoing investigation of a multi-state outbreak of Salmonella serotype Montevideo illnesses. The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), FSIS, state health and agriculture departments, and Daniele International are cooperating in this investigation. The CDC has posted information about the multi-state outbreak on its website ( http://www.cdc.gov/salmonella) but the investigation is ongoing, and has not yet definitively identified a food vehicle(s).

During the course of that investigation, a sample of product found in commerce was tested on behalf of a participating state department of health and found to contain Salmonella, which FSIS has a zero tolerance for in RTE products. The product tested was similar to products bought by customers who later became sick in the Montevideo investigation, but currently there is not a direct link. The Salmonella strain in the tested product does not appear to be the Montevideo strain of interest and further testing of the sample is ongoing at a state health partner laboratory. FSIS is continuing to work with the CDC, affected state public health partners, and the company on the investigation and will update the public on the progress of this investigation as information becomes available.

In addition, the company presented information to FSIS and took the additional action to voluntarily recall all products in commerce associated with black pepper, which the company believes is a possible source of contamination.

The products subject to recall include:

  • 10-ounce packages of "DANIELE NATURALE SALAME COATED WITH COARSE BLACK PEPPER."

  • Catch weight packages of "DANIELE PEPPER SALAME."

  • 9-ounce packages of "BLACK BEAR OF THE BLACK FOREST BABY GENOA PEPPER SALAME."

  • 20-ounce packages of "DANIELE DELI SELECTION, GENOA SALAME, SMOKED SALAME, PEPPERED SALAME, RUSTIC SALAME."

  • 340- and 454-gram packages of "DANIELE SURTIDO FINO ITALIANO, SALAMI GENOA CON PIMIENTA, LOMO CAPOCOLLO, SALAMI CALABRESE."

  • 16-ounce packages of "DANIELE ITALIAN BRAND GOURMET PACK, HOT CALABRESE, PEPPER SALAME, HOT CAPOCOLLO."

  • 8-ounce packages of "DIETZ & WATSON ARTISAN COLLECTION PARTY PLATTER PACK, HOT CALABRESE, PEPPER SALAME, HOT CAPOCOLLO."

  • 8-ounce packages of "DANIELE ITALIAN BRAND GOURMET PACK, HOT CALABRESE, PEPPER SALAME, HOT CAPOCOLLO."

  • 16-ounce packages of "DANIELE GOURMET COMBO PACK, PEPPER SALAME, CAPOCOLLO, CALABRESE."

  • 500-gram packages of "DANIELE ITALIAN BRAND GOURMET PACK EMBALLAGE ASSORTI GOURMET ITALIEN, HOT CALABRESE, PEPPER SALAME, CALABRESE PIQUANT, SALAMI AU POIVRE, HOT CAPOCOLLO, CAPOCOLLO PIQUANT."

  • 8-ounce packages of "BOAR'S HEAD BRAND ALL NATURAL SALAME COATED WITH COARSE BLACK PEPPER."

  • Catch weight packages of "DIETZ & WATSON ARTISAN COLLECTION, BABY GENOA PEPPER SALAME, MADE WITH 100% PORK COATED WITH BLACK PEPPER AND PORK FAT."

  • 20-ounce variety packages of "DANIELE DELI SELECTION, GENOA SALAME, SWEET SOPRESSATA, PEPPERED GENOA, MILANO SALAME."

  • 21-ounce variety packages of "DANIELE GOURMET ITALIAN DELI SELECTION, SWEET SOPRESSATA SALAMI, PEPPERED GENOA SALAMI, HOT SOPRESSATA SALAMI, MILANO SALAMI, SALAMI SOPRESSATA DOUX, SALAMI GENOA POIVRÉ, SALAMI SOPRESSATA PIQUANT, SALAMI MILANO."

  • 7-ounce packages of "DANIELE SALAME BITES PEPPER SALAME."

  • 14-ounce packages of "DANIELE GOURMET ITALIAN DELI SELECTION ASSORTMENT DE FINES CHARCUTERIE ITALIENNE, SWEET SOPRESSATA SALAMI, MILANO SALAMI, SALAMI SOPRESSATA DOUX, SALAMI MILANO."

  • Catch weight packages of "DANIELE NATURALE SALAME COATED WITH COARSE BLACK PEPPER."

  • 32-ounce variety packages of "DANIELE DELI SELECTION, GENOA SALAME, SWEET SOPRESSATA, PEPPERED GENOA, MILANO SALAME."

Each package bears a label with establishment number "EST. 9992" or "EST. 54" inside the USDA mark of inspection. The establishment is recalling all the products listed above which are currently in commerce. These products were distributed to retail establishments nationwide, as well as internationally. When available, the retail distribution list(s) will be posted on FSIS' Web site at http://www.fsis.usda.gov/FSIS_Recalls/Open_Federal_Cases/index.asp.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers (including restaurants) of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Media and consumer questions regarding the recall should be directed to the company's Hotline at (888) 345-4160 and its PR contact, Levick at (202) 973-1335.

Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. Salmonella infections can be life-threatening, especially to those with weak immune systems, such as infants, the elderly, and persons with HIV infection or undergoing chemotherapy. The most common manifestations of salmonellosis are diarrhea, abdominal cramps, and fever within eight to 72 hours. Additional symptoms may be chills, headache, nausea and vomiting that can last up to seven days.

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Jan. 22, 2010

Recall of All GlucoPro Insulin Syringes

Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.

Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.

This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011).

Product Code Lot # Expiry Date
JD+01U3008-5C A08022 2011-11
JD+01U3013-5C A08013 2011-06
JD+01U3013-5C A08017 2011-08
JD+01U3108-5C A08013 2011-06
JD+01U3108-5C A08017 2011-08
JD+03U3008-5C C08022 2011-11
JD+03U3013-5C C08013 2011-06
JD+03U3013-5C C08017 2011-08
JD+03U3108-5C C08013 2011-06
JD+03U3108-5C C08017 2011-08
JD+05U3008-5C B08022 2011-11
JD+05U3013-5C B08013 2011-06
JD+05U3013-5C B08017 2011-08
JD+05U3108-5C B08013 2011-06
JD+05U3108-5C B08017 2011-08

The firm voluntarily recalled the products after learning of the possibility of needle detachment. FDA has been apprised of this action.

No injuries have been reported to date.

Product was distributed nationwide, including Puerto Rico.

Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products.

Consumers with questions may contact the company at 305.599.7174 x249.

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Jan. 21, 2010

The Wisconsin Cheeseman® Recalls Cheese Logs/Cheese Balls

The Wisconsin Cheeseman® announced today that it is recalling cheese log/cheese ball products in conjunction with the voluntary recall initiated by Parkers Farm, Inc. on January 15, 2010. Parkers Farm, Inc., located in Coon Rapids, Minnesota, believes some of its food items have the potential to be contaminated with Listeria monocytogenes bacteria. The recall was a result of a sampling done by the state of Wisconsin and the state of Minnesota.

Nine of the recalled products are cheese logs/cheese balls purchased from Parkers Farm, Inc. and then distributed by The Wisconsin Cheeseman®. These products bear the Parkers Farm logo. None of the other recalled products at Parkers Farm, Inc. was purchased or distributed by The Wisconsin Cheeseman®.

The Wisconsin Cheeseman® Food Gifts Impacted by Recall:

  • Sausage 'N Cheese Logs – Gift #11
  • Cheese Logs & Cutting Board – Gift #87
  • Smorgasbord – Gift #325
  • Cheese Log Trio – Gift #365
  • Cheese Logs – Gift #411
  • Cheese Ball Trio – Gift #441
  • Cheese Logs – Gift #509
  • Snacker Pack – Gift #751
  • Cheese Balls & Sausages – Gift #876

Consumers who have these products in their possession should not consume them. Product should be returned to The Wisconsin Cheeseman® for a refund or replacement. Consumers who believe they may have become ill after consuming these products should contact their health care provider. The Wisconsin Cheeseman® has not received any complaints or reports of illness associated with these products.

Listeria monocytogenes bacteria is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Listeria monocytogenes bacteria often experience fever, severe headaches, stiffness, diarrhea, nausea and abdominal pain. In rare circumstances, infection with Listeria monocytogenes bacteria can result in miscarriage or stillbirth among pregnant women.

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Jan. 20, 2010

Market Day® Frozen Chicken Pot Pie Recalled

Park 100 Foods, Inc., a Kokomo, Ind., establishment, is recalling approximately 19,200 pounds of frozen chicken pot pie products that may contain foreign materials, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The following product is subject to recall:

  • 2.5-pound cartons of "Market Day®, CHICKEN POT PIE, Made With All White Chicken Meat.

Each carton bears a Julian date "28209" which is located on the right side panel, an order number "7138" and the establishment number "P-6882" inside the USDA mark of inspection. The products were produced by Park 100 Foods on October 9, 2009, and were distributed by Market Day through Internet or catalog sales in:

  • Delaware
  • Florida
  • Illinois
  • Indiana
  • Iowa
  • Kentucky
  • Maryland
  • Michigan
  • Missouri
  • New Jersey
  • Ohio
  • Pennsylvania
  • Virginia
  • West Virginia
  • Wisconsin

The problem was discovered after Market Day received a customer complaint about finding metal straight pins in the product. FSIS has not received any consumer complaints or reports of injury at this time. Anyone concerned about an injury from consumption of this product should contact a physician.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers (including restaurants) of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumers with questions about the recall should contact company Corporate Director of Quality Jim Fish at (317) 853-4280. Media with questions about the recall should contact company President Gary Meade at (317) 853-4202.

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Jan. 20, 2010

Rolaids Antacid Tablets Packaged in Bottles Recalled

Health Canada is informing Canadians that Rolaids antacid tablets packaged in bottles of 150 and 100 counts are being voluntarily recalled in Canada by the distributor, McNeil Consumer Healthcare (Canada), Division of Johnson & Johnson Inc. The recall comes in light of reports in the U.S. of an unusual mouldy, musty, or mildew-like odour that was, in some cases, associated with nausea, stomach pain, vomiting and diarrhea.

The distributor has confirmed that the recall does not extend beyond the Rolaids antacid tablets packaged in bottles of 150 and 100 counts. The recalled products are:

Description DIN/NPN UPC (EA) LOT Numbers
ROLAIDS® Regular Strength Original 150s NPN 02239904 060093200206 AAA526, ACA014, ADA269, AFA052
ROLAIDS® Regular Strength Spearmint 150s NPN 02239904 060093200213 ABA151, ABA400, ABA401, ABA402, AEA013, ALA257
ROLAIDS® Extra Strength Freshmint 100s NPN 02240505 060093200237 SSA156, ABA398, SSA236, ADA181, AHA044, AEA198
ROLAIDS® Extra Strength Mixed Fruit 100s NPN 02240505 060093200244 AAA249, ACA259, AEA196, AFA318, ALA133
ROLAIDS® Multi-Symptom Berry 100s DIN 02247314 060245200443 ABA535, AHA075

Rolaids antacids are widely used to relieve acid indigestion and heartburn. Based on an ongoing investigation by the U.S. manufacturer, McNeil Consumer Healthcare, the unusual smell has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials used in the affected product.

The health effects of this chemical have not been well studied. According to the U.S. manufacturer, all of the reactions (e.g. nausea, stomach pain, diarrhea, etc.) reported in the U.S. to date have been temporary and non-serious.

Consumers who have purchased any of the above-listed products and who have concerns about their health should speak to a health care professional. The distributor advises consumers who have purchased bottles of Rolaids antacid tablets to stop using the product and to contact McNeil Consumer Healthcare (Canada) at 1-800-661-4659, Monday-Friday 8a.m. to 8p.m. EST for instructions on how to return or replace the product.

Consumers requiring more information about this information update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

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Jan. 18, 2010

Allergy Alert on Bravo Ice Creams

Product Description
150 ml Cardboard wrapped ice cream cones.
No Best Before date specified however the current English label states '1 year from data of production' with the dates of production on label stated as 2009 June 18, 2009 October 15 and 2009 July 30.

Identifying Features
APN/EAN/TUN Numbers: 1880101950693 9, 1880101950692 2 & 188010195060 8

Hazards:
Illness

Defects:
Labeling – undeclared allergens – milk and peanut

Where Product Was Sold:
* NSW

Traders Who Sold Product:
The products are sold through Asian (Korean and Chinese) retail outlets.

Supplier:
Dong Nam Trading

Comments:
Return to place of purchase for full refund

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Jan. 18, 2010

Huntington Meat Packing Recalls Beef Products

Huntington Meat Packing Inc., a Montebello, Calif. establishment, is recalling approximately 864,000 pounds of beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The problem was discovered during a Food Safety Assessment (FSA) by FSIS personnel. The FSA led to the determination that a further investigation of establishment records was warranted. The investigation is ongoing and the following products are subject to recall.

The following products, consisting of all ground beef products produced by the plant from January 5, 2010 to January 15, 2010, are subject to recall:

    • 40 lb. boxes of "Huntington Meats Ground Beef"
    • 40 lb. boxes of "HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING"
    • 40 lb. boxes of "BEEF BURRITO FILLING MIX"
    • 10 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
    • 20 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
    • 10 lb. boxes of "El Rancho MEAT & PROVISION ALL BEEF PATTIES"

    Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on a label. The products were produced between January 5, 2010, and January 15, 2010, and were shipped to distribution centers, restaurants, and hotels within the State of California.

    FSIS has received no reports of illnesses associated with consumption of these products. Individuals concerned about an illness should contact a physician.

    During a subsequent review of the establishment's records, FSIS also determined additional products produced and shipped in 2008 to be adulterated because they may have been contaminated with E. coli O157:H7. As a result, the following products produced from February 19, 2008 to May 15, 2008, are subject to recall:

    • 40 lb. boxes of "Huntington Meats Ground Beef"
    • 40 lb. boxes of " HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING"
    • 40 lb. boxes of "BEEF BURRITO FILLING MIX"
    • 10 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
    • 20 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
    • 10 lb. boxes of "El Rancho MEAT & PROVISION ALL BEEF PATTIES"

    Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on a label. The products were produced between February 19, 2008, and May 15, 2008, and were shipped to distribution centers, restaurants, and hotels within the State of California.

    While these products are normally used fresh, the establishment is taking this action out of concern that some product may still be frozen and in commerce.

    FSIS has received no reports of illnesses associated with consumption of these recalled products. Individuals concerned about an illness should contact a physician.

    E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea, dehydration, and in the most severe cases, kidney failure. The very young, seniors and persons with weak immune systems are the most susceptible to foodborne illness.

    FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers (including restaurants) of the recall and that steps are taken to make certain that the product is no longer available to consumers.

    FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef or ground beef patties that have been cooked to a temperature of 160° F. The only way to be sure ground beef is cooked to a high enough temperature to kill harmful bacteria is to use a food thermometer to measure the internal temperature.

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Jan. 18, 2010

FDA Warns Consumers about Counterfeit Alli

The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).

Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores.

The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

  • Outer cardboard packaging missing a "Lot" code
  • Expiration date that includes the month, day, and year (e.g., 06162010)
  • Authentic Alli expiration date includes only the month and year (e.g.,: 05/12)
  • Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product
  • Plain foil inner safety seal under the plastic cap without any printed words
  • The authentic product seal is printed with "SEALED for YOUR PROTECTION"
  • Contains larger capsules with a white powder, instead of small white pellets

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site ( http://www.fda.gov/OCI).

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Pictures of counterfeit Alli samples provided by GSK are shown below.

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Jan. 15, 2010

Recall of Pine Nuts Because of Possible Health Risk

Hines Nut Company has initiated a recall of 270 packages of Pine Nuts, packaged under the brand name Harris Teeter Farmers Market. The Pine Nuts were purchased from Red River Foods in Camarillo, CA, and have the potential to be contaminated with Salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recalled product was sold in 8 oz foam trays wrapped in cellophane and carry the UPC code 0 72036 88121 0. The Pine Nuts were distributed solely to Harris Teeter Markets in North Carolina.

Consumers who purchased this product between December 30, 2009, and January 14, 2010 should contact Hines Nut Company for information on how to return the product for a refund.

There have been no complaints or any reported illnesses related to the products to date. The problem was discovered through routine sampling by the supplier, Red River Foods. Consumers with questions may contact Hines Nut Company at 214-939-0253 (M-F, 6:30 AM to 3:30 PM CDT).

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Jan. 15, 2010

Nationwide Recall of Certain Body Building Products

MuscleMaster.com, Inc. ("MuscleMaster.com") announced today that it is conducting a voluntary nationwide recall of all lots and expiration dates of the seventeen below listed dietary supplements sold between June 1, 2009 and November 17, 2009 (hereinafter "Recalled Products").

FDA informed MuscleMaster.com that it believes that the Recalled Products contain ingredients that are steroids. Specifically, FDA advised MuscleMaster.com of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." While MuscleMaster.com cannot independently confirm the FDA's concerns, that any one or more of the Recalled Products in fact contain these ingredients, MuscleMaster.com is undertaking this voluntary recall out of an abundance of caution and in deference to FDA's stated concerns.

Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

MuscleMaster.com is recalling the following products:

  • Advanced Muscle Science Dienedrone, 60 caps
  • Advanced Muscle Science Liquidrone, 60 ml
  • Anabolic Formulation M1, 4AD, 60 caps
  • Anabolic Formulations 1, 4 AD, 60 caps
  • Anabolic Xtreme Hyperdrol X2
  • Anabolic Xtreme 3-AD, 90 caps
  • BCS Labs Testra-Flex, 90 caps
  • Competitive Edge Labs M-Drol, 90 Caps
  • Competitive Edge Labs P-Plex, 90 caps
  • Competitive Edge Labs X-Tren, 90 caps
  • 4Ever Fit D-Drol, 60 caps
  • Gaspari Novedex XT 60 Caps
  • Gaspari Halodrol Liquigels, 60 gels
  • iForce 1,4 AD BOLD 200, 60 Caps
  • iForce MethaDROL, 90 caps
  • iForce Dymethazine, 60 caps
  • Monster Caps, 60 caps

MuscleMaster.com has not received any complaints of illness or injury regarding these products. FDA is concerned the products may present a safety risk to consumers who ingest them. MuscleMaster.com is an internet retailer and did not manufacture or formulate these products. MuscleMaster.com's decision to implement this recall is not, and should not be construed as, an admission that their decision to sell these products was in violation of the law. In addition it is not, and should not be construed as, an admission that these products are not in compliance with the law. This recall is solely a reflection of MuscleMaster.com's deference to the FDA's stated concerns with these products.

Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to using one or more of the products.

Consumers should return any unused products purchased on the Company's site to the Company. For instructions on how to return Recalled Products please call (1-800-240-4767) or e-mail (returns@musclemaster.com) the Company.

Any adverse events that may be related to the use of the Recalled Products should be reported to the FDA's MedWatch Adverse Event Reporting program online or by phone 1-800-FDA-1088.

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Jan. 15, 2010

Parkers Farms Extends Previous Recall

Parkers Farm, Inc. of Coon Rapids, Minnesota today expanded the previously announced recall of products to include all date codes because they have the potential to be contaminated with listeria monocytogenes, an organism which can cause serious and sometimes fatal infection in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

No illnesses have been reported to date in connection with this problem.

The recall originally announced 01/12/2010 affected product with sell by dates of specific ranges. The expanded recall now includes all products and all sell by dates. The recalled products were distributed nationwide in the following retail stores:

  • Hy-Vee
  • Cub
  • Rainbow
  • Byerlys Lund's
  • Target
  • Whole Foods
  • Jewel
  • Dominick's
  • Marsh
  • Price Chopper
  • Shop Rite
  • Nash Finch
  • Sam's Club
  • Costco
  • Safeway

The following recalled products were sold under the Parker Farm or Parkers label:

  • 12 ounce & 16 ounce peanut butter in square plastic containers (tub with snap on lid), regular and organic varieties are creamy, crunchy, honey creamy and honey crunchy with sell by dates on or before 12/31/2010.

  • 34 ounce peanut butter in round plastic containers (tub with snap on lid), varieties are creamy and crunchy with sell by dates on or before 09/30/2010.

  • 7 ounce bagel spreads in white plastic containers (tub with snap on lid), varieties are garden veggie, wild berry, strawberry, apple cinnamon and honey walnut with sell by dates on or before 06/30/2010.

  • 12 ounce & 14 ounce dips & spreads in square plastic containers (tub with snap on lid), varieties are jalapeno nacho, pimento and salsa con queso with sell by dates on or before 09/30/2010.

  • 8 ounce, 12 ounce and 16 ounce cold pack cheese in round or square plastic containers (tub with snap on lid), varieties are sharp cheddar, bacon, onion, smoked cheddar, Swiss almond, horseradish, garlic, port wine, and swiss & cheddar with sell by dates on or before 12/31/2010.

  • 16 ounce salsa in square plastic containers (tub with snap on lid), varieties are hot, mild, garlic, black bean and fire roasted with sell by dates on or before 04/30/2010.

  • 32 ounce salsa in plastic jugs (clear jug with screw cap), varieties are hot, mild, garlic, and black bean with sell by dates on or before 04/30/2010.

  • 128 ounce salsa in plastic jugs (clear jug with screw cap), varieties are hot, fire roasted, mild and garlic with sell by dates on or before 04/30/2010.

  • 8 ounce, 9 ounce, 10 ounce Balls & Logs (in film over wrap), varieties are sharp cheddar, port wine, smoky bacon, ranch, garlic, jalapeno, pimento, spinach, jajik, beer and chorizo with sell by dates on or before 01/05/2011.

  • 5#, 5.5#, 10#, 30# Parker Farm cold pack cheese (white tub with snap on lid), varieties are sharp cheddar, onion, bacon, smoked cheddar, swiss almond, horseradish, garlic, port wine, and swiss & cheddar with sell by dates on or before 09/30/2010.

OTHER LABELS AFFECTED BY THIS RECALL:

  • 16 ounce Happy Farms cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and swiss almond with sell by dates on or before 12/31/2010.

  • 8 ounce Kroger cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and swiss almond with sell by dates on or before 12/31/2010.

  • 8 ounce Central Markets cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish with sell by dates on or before 12/31/2010.

  • 14 ounce Central Markets salsa con queso in round plastic containers (tub with snap on lid) with sell by dates on or before 09/30/2010.

  • 16 ounce Central Markets salsa in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish with sell by dates on or before 04/30/2010.

  • 8 ounce Dutch Farms cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish, and swiss & cheddar with sell by dates on or before 12/31/2010.

  • 7 ounce Dutch Farms cream cheese spreads in round plastic containers (tub with snap on lid), varieties are strawberry, wild berry, honey walnut & apple cinnamon with sell by dates on or before 06/30/2010.

  • 8 ounce Crystal Farms cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, bacon and jalapeno cheddar with sell by dates on or before 12/31/2010.

  • 8 ounce Heluva Good cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and horseradish cheddar with sell by dates on or before 12/31/2010.

  • 8 ounce Amish Classic cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish with sell by dates on or before 12/31/2010.

  • 10 ounce Amish Classic cheese balls & logs (in film over wrap), varieties are cheddar, port wine, ranch, smoky bacon, beef n onion with sell by dates on or before 01/05/2011.

  • 128 ounce San Pablo salsa in plastic jugs (clear jug with screw cap), varieties are fire roasted and mild with sell by dates on or before 04/30/2010.

  • 12 ounce Century Resources cold pack cheese food (tub with snap on lid), varieties are sharp cheddar, horseradish, bacon with a sell by date of xxx9 (the first 3 digits aren't important, but the last digit must be a 9)

  • 12 ounce Century Resources pimento spread (tub with snap on lid) with a sell by date of xxx9 (the first 3 digits aren't important, but the last digit must be a 9.

  • 8 ounce and 12/12 ounce Century Resources cheese ball & log (in film over wrap) sharp cheddar with a sell by date of xxx9 (the first 3 digits aren't important, but the last digit must be a 9)

  • 12 ounce Century Resources salsa con queso (tub with snap on lid) with a sell by date of xxx9 (the first 3 digits aren't important, but the last digit must be a 9)

  • 4#, 5.5# Block & Barrel cold pack cheese (white tub with snap on lid), varieties are sharp cheddar, swiss almond, horseradish, port wine and pimiento spread with packed on dates on or before 12/30/2009.

  • 30# Block & Barrel sharp cheddar cold pack cheese (white pail with snap on lid) with packed on dates on or before 12/30/2009.

  • 5# Cobblestone cold pack cheese (white tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish with sell by dates on or before 06/30/2010.

  • 30# Cobblestone sharp cheddar cold pack cheese (white pail with snap on lid) with sell by dates on or before 06/30/2010.

  • 5# Biery label cold pack cheese (white tub with snap on lid), varieties are sharp cheddar and port wine with sell by dates on or before 09/30/2010.

  • 5# Dierks Waukesha cold pack cheese (white tub with snap on lid), varieties are sharp cheddar, port wine, horseradish, swiss almond with sell by dates on or before 09/30/2010.

The recall was a result of a sampling done by the state of Wisconsin and the state of Minnesota which revealed that some finished products contained the bacteria. The state of Minnesota, FDA, and the company continue their investigation as to what caused the problem. No illnesses have been reported to date in connection with this problem.

Consumers who have purchased these products are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at (800) 869-6685.

For the ultimate safety of our customer and in order to create less confusion for them, Parkers Farm, Inc. Has decided to include all of its products, regardless of date codes in this recall.

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Jan. 15, 2010

Voluntarily Recalls Certain Over-The-Counter (OTC) Products

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare has voluntarily recalled certain lot numbers following an investigation of consumer reports of an unusual moldy, musty, or mildew-like odor. The odor was associated with temporary, non-serious gastrointestinal symptoms, including nausea, stomach pain, vomiting, and/or diarrhea.

This recall expands an earlier recall of acetaminophen 100-count bottles with EZ open caps labeled Tylenol Arthritis that began in late 2009. Some of the medications included in this expanded recall are used in the treatment of pain, like:

  • Children's Motrin
  • Children's Meltaway Tylenol
  • Extra Strength Tylenol
  • Tylenol 8 hour
  • Tylenol Arthritis
  • Tylenol PM
  • Regular Strength Tylenol
  • Benadryl
  • Motrin IB
  • Rolaids
  • Simply Sleep
  • St. Joseph Aspirin

Specific lot numbers affected by this recall can be found below:

FULL RECALLED PRODUCT LIST (PDF - 179.38 KB)

To find if you are in possession of any of the affected products, look on the side of the bottle label for the lot number.

Individuals who may have ANY of these lots in their possession should:

  • Stop taking the medication.
  • Contact your healthcare provider if you've recently taken these medications
  • Report any adverse reactions to the FDA's MedWatch Program by:
    • Fax: 1-800-FDA-0178
    • Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
    • Internet: www.fda.gov/medwatch

The public may direct questions to McNeil Consumer Healthcare at www.mcneilproductrecall.com or 1-888-222-6036 (Monday-Friday, 8:00 a.m. to 10:00 p.m. Eastern time and Saturday-Sunday 9:00 a.m. to 5:00 p.m. Eastern time).

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Jan. 15, 2010

Roasted Hazelnuts Recalled

PEO Chapter FO of Ashland, Oregon is recalling 75 - 1 lb packages of roasted hazelnuts, because they have the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The roasted hazelnuts were distributed through two beauty salons: Victoria's and Strand's both located in Ashland, Oregon.

The roasted Hazelnuts were packaged in 1 lb. plastic bags and labeled "Hazelnuts, Roasted $7.00". No other codes, expiration date, or UPC is found on the package.

This recall was the result of a routine sampling of product by the FDA at the company who processes the hazelnuts for our supplier. The company has ceased the production and distribution of the product as FDA and the company continues their investigation as to what caused the problem.

Consumers who have purchased the roasted hazelnuts from these stores are urged to return it and contact PEO at 1-541-482-2290, Monday-Friday, 9:00 AM-3:00 PM PST.

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Jan. 15, 2010

Pacific Panel Heaters Recalled

Product Description
IXL Portable or Wall Mounted Panel Heaters
Model No. 72625 (1800W) 72645 and 72646 (2400W)

Identifying Features
Model No. 72625 (1800W) 72645 and 72646 (2400W)

Hazards
The defects may may lead to overheating resulting in potential fire or hazardous melting of internal product components.

Defects
Sampford IXL has received reports of internal failures.

Dates Available for Sale
* January 2005 - September 2009

Where Product Was Sold
* ACT
* NSW
* QLD
* SA
* TAS
* VIC
* WA

Supplier
Sampford IXL Pty Ltd
Supplier's web site
http://www.samfordixl.com.au

Comments
Customers must immediately stop using the heater and contact Sampford IXL for a refund and to make arrangements for collection by Sampford IXL. If you are unsure of your heater's model number, please call for assistance. Please do not attempt to remove and disconnect permanently wired heaters. Sampford IXL may be contacted on 1800 035 410 (in Australia) or 0800 760 028 (if you are in New Zealand) Mon-Fri between 9am - 5pm AEDT.

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Jan. 14, 2010

Health Alert for Merrick Beef Filet Squares Dog Treats

The U. S. Food and Drug Administration is warning consumers not to use Merrick Beef Filet Squares for dogs distributed by Merrick Pet Care with a package date of "Best By 111911" because the product may be contaminated with Salmonella. The product was distributed nationwide through retail stores and Internet sales.

Although no illnesses associated with these products have been reported, the FDA is advising consumers in possession of these products not to handle or feed them to their pets.

In December 2009, the FDA conducted routine testing of Merrick Beef Filet Squares and detected a positive finding for Salmonella. A follow-up inspection found deficiencies in the packaging and manufacturing processes.

Salmonella can affect both humans and animals. People handling dry pet treats can become infected with Salmonella, especially if they have not thoroughly washed their hands after having contact with the treats or any surfaces exposed to these products. Consumers should dispose of these products in a safe manner by securing them in a covered trash receptacle.

Healthy people infected with Salmonella may experience some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Although rare, Salmonella can result in more serious ailments including arterial infections, endocarditis (inflammation of the lining of the heart), arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their health care provider immediately.

Pets with Salmonella infections may become lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets may experience only a decreased appetite, fever and abdominal pain. Infected, but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed any of the affected product or is experiencing any of these symptoms, contact your veterinarian immediately.

The affected Merrick Beef Filet Squares were packaged in a 10-ounce green, red and tan re-sealable plastic bag. The "best by" date is imprinted on the top portion of the bag, which is torn off when the bag is opened. The FDA recommends that consumers who are unable to determine the "best by" date discontinue use of the product.

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Jan. 13, 2010

Recall on select HAPPYTOT & HAPPYBABY Stage 1, 2, 4 Pouch Meals

The FDA is recommending that the public not consume any varieties of HAPPYTOT Stage 4 and certain varieties of HAPPYBABY Stage 1 and Stage 2 baby foods in pouches distributed by Nurture Inc. The firm is recalling these products because some pouches are leaking or swollen. Swollen or leaking pouches may indicate problems with the product, including possible contamination by bacteria that can cause illness, or that the packaging has been compromised and is at risk of bacterial contamination.

The varieties of these products that should not be consumed are as follows:

  • HAPPYTOT - Green bean, pear & peas - 4.22 OZ. (120g) - UPC 8 52697 00127 9
  • HAPPYTOT - Sweet potato, carrot, apple & cinnamon - 4.22 OZ. (120g) - UPC 8 52697 00128 6
  • HAPPYTOT - Spinach, mango & pear - 4.22 OZ. (120g) - UPC 8 52697 00129 3
  • HAPPYTOT - Butternut squash & apple - 4.22 OZ. (120g) - UPC 8 52697 00130 9
  • HAPPYTOT - Banana, peach, coconut & prunes - 4.22 OZ. (120g) - UPC 8 52697 00131 6
  • HAPPYTOT - Banana, peach & mango - 4.22 OZ. (120g) - UPC 8 52697 00132 3
  • HAPPYBABY - Mango - 3.5 OZ. (99g) - UPC 8 52697 00134 7
  • HAPPYBABY - Spinach Mango Pear - 3.5 OZ. (99g) - UPC 8 52697 00139 2
  • HAPPYBABY - Apricot Sweet Potato - 3.5 OZ. (99g) - UPC 8 52697 00136 1

The above meals are packaged in plastic pouches with plastic caps and are sold at retail stores nationwide. To determine if a specific product is part of this recall, consumers should examine product packaging for expiration date codes between October 2010 and January 2011. These expiration date codes are printed as the first seven characters of a 15-character string.

After receiving a consumer complaint of a swollen pouch, the FDA contacted the company, Nurture Inc., of Brooklyn, N.Y. The agency began an investigation and found additional pouches that were swollen or leaking. FDA is conducting tests for possible bacterial contamination.

The FDA is also conducting an inspection at the contract manufacturer of these products to review its overall manufacturing process. No illnesses have been reported to the FDA to date.

Consumers who have served or consumed these products and become ill should contact their health providers immediately and report that to their FDA district office and to the company.

Consumers who see swelling, leaking, or packaging problems in any HAPPYTOT Stage 4 or HAPPYBABY Stage 1 or Stage 2 pouched baby food products should discard the products in a way that will keep people and pets from retrieving them, and should wash their hands thoroughly after handling the packages. Store personnel who handle products involved in the company recall should wash their hands thoroughly after handling packages of these products.

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Jan. 13, 2010

Pork Skin Products Recalled

On January 9, 2010, the Rudolph Foods Company, Inc., a San Bernardino, Calif., establishment recalled approximately 205 pounds of pork skin products because they were inadvertently mislabeled and contain an undeclared allergen, milk. Milk is a known potential allergen, which is not declared on the label.

The following product was subject to recall:

  • 3.5-ounce packages of "Pepe's Gigante Louisiana Hot Sauce Flavored Cracklins." Each package bears a use by date of "03/19/2010," as well as the establishment number "EST. 0525" inside the USDA mark of inspection.

Today, January 13, 2010, the FDA has released a list - in PDF format - of the retail establishments which sold this recalled product.

Click Here for New Retail List

The pork skin products were produced on December 18, 2009, and were sent to distributors in the Southern California region.

The problem was discovered by the company following a product check. FSIS has received no reports of adverse reactions due to consumption of these products. Anyone concerned about an allergic reaction should contact a physician.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumer and media inquiries regarding the recall should be directed to Todd Zwiebel, Corporate QA Manager, at 1-800-342-7546, ext. 112.

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Jan. 13, 2010

Heluva Good Cold Pack Cheese Products Recalled

HP Hood is recalling select Heluva Good branded 8 oz. plastic cup containers of Cold Pack Cheese Food because they may contain Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness and nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

No illnesses have been reported to date in connection with the product and codes listed below.

  • 8 oz. plastic cup containers - Heluva Good Port Wine Cold Pack Cheese Food - UPC 73570 55503 - Sell by date 11/15/2010 thru 12/15/2010

  • 8 oz. plastic cup containers - Heluva Good Sharp Cheddar Cold Pack Cheese Food - UPC 73570 55501 - Sell by date 11/15/2010 thru 12/15/2010

The recalled products were distributed in stores in the following states:

  • Connecticut
  • Delaware
  • Maine
  • Maryland
  • Massachusetts
  • New Hampshire
  • New Jersey
  • New York
  • Ohio
  • Pennsylvania
  • Rhode Island
  • Vermont
  • Virginia
  • West Virginia

The recall is being done as a precaution and is the result of a sampling done by the state of Wisconsin (from the facility that co-packs products under the Heluva Good brand) which revealed that some finished products contained the bacteria.

Consumers who have purchased these products are urged to return the products to the place of purchase for a full refund. Consumers with questions can call Heluva Good Consumer Affairs at (800) 242-2423.

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Jan. 12, 2010

Parkers Farm, Inc. Recalls Several Products

Parkers Farm, Inc. of Coon Rapids, Minnesota is recalling products because they have the potential to be contaminated with Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infection in children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnancy women.

No illnesses have been reported to date in connection with this problem.

The recalled products were distributed nationwide in the following retail stores:

  • Hy-Vee
  • Cub
  • Rainbow
  • Byerlys Lund's
  • Target
  • Whole Foods
  • Jewel
  • Dominick's
  • Marsh
  • Price Chopper
  • Shop Rite
  • Nash Finch
  • Sam's Club
  • Costco
  • Safeway

The following products were sold under the Parkers Farm or Parkers Label:


Size Package Type Product Varieties Sell By Dates
16 oz square plastic containers (tub with snap on lid) Peanut Butter Creamy, Crunchy, Honey Creamy, Honey Crunch 11/14/2010 thru 12/31/2010**
34 oz round plastic containers (tub with snap on lid) Peanut Butter Creamy, Crunchy 8/11/2010 - 9/30/2010**
7 oz white plastic containers (tub with snap on lid) Bagel Spreads Garden Veggie, Wild Berry, Strawberry, Apple Cinnamon, Honey Walnut 5/13/2010 - 6/30/2010**
14 oz square plastic containers (tub with snap on lid) Dips & Spreads Jalapeno Nacho, Pimento, Salsa Con Queso 8/11/2010 - 9/30/2010**
8, 12 and 16 oz round or square plastic containers (tub with snap on lid) Cold Pack Cheese Sharp Cheddar, Bacon, Onion, Smoked Cheddar, Swiss Almond, Horseradish, Garlic, Port Wine, Swill & Cheddar 11/14/2010 - 12/31/2010**
16 oz square plastic containers (tub with snap on lid) Salsa Hot, Mild, Garlic, Black Bean, Fire Roasted 3/14/2010 - 4/30/2010**

Other labels effected by this recall:


Size Package Type Product Varieties Sell By Dates
16 oz round plastic containers (tub with snap on lid) HAPPY FARMS Cold Pack Cheese Sharp Cheddar, Port Wine, Swiss Almond 11/24/2010 - 12/10/2010**
8 oz round plastic containers (tub with snap on lid) KROGER Cold Pack Cheese Sharp Cheddar, Port Wine, Swiss Almond 11/18/2010 - 12/15/2010**
8 oz round plastic containers (tub with snap on lid) CENTRAL MARKETS Cold Pack Cheese Sharp Cheddar, Port Wine, Swiss Almond, Horseradish 12/9/2010**
14 oz round plastic containers (tub with snap on lid) CENTRAL MARKETS Salsa Con Queso   8/16/2010**
16 oz round plastic containers (tub with snap on lid) CENTRAL MARKETS Salsa Sharp Cheddar, Port Wine, Swiss Almond, Horseradish 3/17/2010 - 3/24/2010**
8 oz round plastic containers (tub with snap on lid) DUTCH FARMS COLD PACK CHEESE Sharp Cheddar, Port Wine, Swiss Almond, Horseradish, Swiss & Cheddar 11/16/2010 - 11/18/2010**

**NOTE: Sell by dates are clearly printed on container ½ inch from top

The recall was a result of a sampling done by the state of Wisconsin and the state of Minnesota which revealed that some finished products contained the bacteria. FDA and the company continue their investigation as to what caused the problem. No illnesses have been reported to date in connection with this problem.

Consumers who have purchased these products are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at (800) 869-6685.

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Jan. 12, 2010

Beef Products Recalled Due to Possible E. Coli Contamination

Adams Farm Slaughterhouse, LLC., an Athol, Mass., establishment, is recalling approximately 2,574 pounds of beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

This recall was initiated after the Massachusetts Department of Public Health (MDPH) confirmed a positive ground beef sample for E. coli O157:H7, which it collected during an epidemiological investigation. Working in conjunction with the Massachusetts Department of Public Health (MDPH), FSIS determined that there is an association between the ground beef products and an illness in the state of Massachusetts. FSIS is continuing to work with the MDPH on the investigation. Anyone with signs or symptoms of foodborne illness should consult a physician.

The following products are subject to recall:

  • 1,025-pounds of "Beef Cuts and Ground" packed for Mazzarese
  • 697-pounds of "Beef Cuts and Ground" packed for Side Hill Farm
  • 852-pounds of "Beef Cuts and Ground" packed for Sweet Water Farm

Each package bears a label with the establishment number "EST. 5497" inside the USDA mark of inspection as well as the packaging date of "11/11/2009." The beef products were distributed to private owners on three separate farms in the state of Massachusetts.

E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea, dehydration, and in the most severe cases, kidney failure. The very young, seniors and persons with weak immune systems are the most susceptible to foodborne illness. Individuals concerned about an illness should contact a physician.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef or ground beef patties that have been cooked to a temperature of 160° F. The only way to be sure ground beef is cooked to a high enough temperature to kill harmful bacteria is to use a food thermometer to measure the internal temperature.

Media and consumer questions regarding the recall should be directed to the company's Business Manager, Edward Maltby, at (413) 427-7323.

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Jan. 11, 2010

Allergy Alert on Pepe's Louisiana Hot Gigante Cracklins

Rudolph Foods is recalling 39 cases of Pepe's Louisiana Hot Gigante Cracklins, 3,537 cases of 7-Select Louisiana Hot Onion Rings and 420 cases of Rudolph's Louisiana Hot OnYums, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Pepe's Louisiana Hot Gigante Cracklins were distributed in Southern California. Rudolph's Louisiana Hot OnYums and 7-Select Louisiana Hot Onion Rings were distributed in:

  • California
  • Nevada
  • Oregon
  • Arizona
  • Washington State

The products being recalled are the:

  • 3.5 oz. Pepe's Louisiana Hot Gigante Cracklins - UPC # 0-24622-51131-7 - Code date March 19, 2010

  • 1 5/8 oz. 7-Select Louisiana Hot Onion Rings - UPC #0-52548-05785-5 - Code dates February 26, 2010 through April 30, 2010

  • 8 oz. Rudolph's Louisiana Hot OnYums - UPC # 0-24622-57079-6 - Code dates February 5, 2010 and March 12, 2010

Please reference 4-digit manufacturing codes that include an "s", located beneath the sell by date, for affected products.

No illnesses have been reported to date in connection with this problem. The recall was initiated after it was discovered that the manufacturer inadvertently placed the wrong packaging on these products that did not reflect the presence of the milk ingredient.

Consumers who have purchased Pepe's Louisiana Hot Gigante Cracklins, 7-Select Louisiana Hot Onion Rings or Rudolph's Louisiana Hot OnYums are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Todd Zwiebel, Corporate Quality Assurance Manager, Rudolph Foods at 800-342-7546 ext.112.

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Jan. 11, 2010

FDA Approves New Drug for Rheumatoid Arthritis

The U.S. Food and Drug Administration approved Actemra (tocilizumab) on Friday to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis.

Actemra recommended use is limited to patients who have failed other approved therapies because of serious safety concerns that were noted in clinical studies. These safety concerns include elevated liver enzymes, elevated Low-density lipoprotein (LDL) or bad cholesterol, hypertension, and gastrointestinal perforations.

"Physicians and patients need to be aware of the risk of serious adverse effects of Actemra and make informed decisions regarding its benefits and risks in the treatment of individual patients," said Bob Rappaport, M.D., director of the Division of Analgesics, Anesthetics and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

The FDA is requiring the sponsor to conduct a post-marketing clinical trial to further evaluate the long-term safety of Actemra. Specifically, the FDA wants to evaluate the impact of elevated LDL cholesterol and blood pressure seen in some patients in shorter-term trials on the cardiovascular health of patients treated with Actemra.

In addition, a Risk Evaluation and Mitigation Strategy (REMS) will require the drug sponsor to implement a Communication Plan for physicians informing them how to appropriately monitor their patients for liver and/or gastrointestinal side effects. The REMS will include a Medication Guide to ensure that patients are informed of the benefits and risks of Actemra.

Actemra works by blocking the action of interleukin-6, an immune system protein that is overabundant in people with rheumatoid arthritis.

The effectiveness and safety of Actemra was determined in five clinical trials in adult patients with active rheumatoid arthritis. In all of the trials, patients treated with Actemra experienced greater improvement in their tender or swollen joints than patients treated with a placebo.

The most common adverse reactions in clinical trials were:

  • upper respiratory tract infections
  • headache
  • inflammation of the nose or nasal passage
  • high blood pressure and increased liver enzymes

Elevations in the LDL or bad cholesterol were also seen in some patients, some of whom required the addition of lipid lowering agents.

Patients treated with Actemra are at increased risk for developing serious infections. Most patients who developed these infections in clinical trials were also taking other drugs that suppress the immune system such as methotrexate or corticosteroids.

Actemra is marketed by San Francisco-based Genentech Inc., a subsidiary of the Roche Group.

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Jan. 9, 2010

Pork Skin Products Recalled

Rudolph Foods Company, Inc., a San Bernardino, Calif., establishment, is recalling approximately 205 pounds of pork skin products because they were inadvertently mislabeled and contain an undeclared allergen, milk, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. Milk is a known potential allergen, which is not declared on the label.

The following product is subject to recall:

  • 3.5-ounce packages of "Pepe's Gigante Louisiana Hot Sauce Flavored Cracklins." Each package bears a use by date of "03/19/2010," as well as the establishment number "EST. 0525" inside the USDA mark of inspection.

The pork skin products were produced on December 18, 2009, and were sent to distributors in the Southern California region.

The problem was discovered by the company following a product check. FSIS has received no reports of adverse reactions due to consumption of these products. Anyone concerned about an allergic reaction should contact a physician.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumer and media inquiries regarding the recall should be directed to Todd Zwiebel, Corporate QA Manager, at 1-800-342-7546, ext. 112.

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Jan. 7, 2010

Recall of Boiled Horse Mackerels

Bao Ding Seafood of New York, NY 10002 is recalling Boiled Horse Mackerel, because it has the potential to be contaminated with clostridium botulinum, a bacterium which can cause life-threatening illness or death.

Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, causes the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

The recalled Boiled Horse Mackerel packaged in a vacuum packed plastic bag, net weight 450g, was sold in New York State.

The recall Boiled Horse Mackerel was discovered by NYS Dept. of Agriculture and Market food inspector during a routine inspection and subsequent analysis of product by food lab personnel confirming fish was not eviscerated prior to processing.

No illnesses have been reported to date in connection with this problem. Consumers who have Boiled horse Mackerel are advised not to eat it, but should return it to the place of purchase. Consumer with questions may contact the Jenny Lin at 212-965-9738.

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Jan. 6, 2010

Recall of Red Bean Jelly Popsicle

Product Description:
DATE MARKING: Best Before date: 6 July 2011
APN/EAN/TUN NUMBER: 4711634002822
PACKAGE DESCRIPTION: Paper Wrap
PACKAGE SIZE: 5 popsicles per packet, 75 g each
COUNTRY OF ORIGIN: Taiwan
Public contact phone number: 02 9604 8886

Identifying Features:
APN/EAN/TUN NUMBER: 4711634002822

Hazards:
Allergic reaction

Defects:
Labeling - undeclared allergen (milk powder)

Dates Available for Sale:
December 2009 - January 2010

Where Product Was Sold:
NSW

Traders Selling Product:
Sold in Sydney Chinese shops only

Supplier:
Mani Fold Food Trading Pty Ltd

Comments:
Return to place of purchase for a full refund

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Jan. 6, 2010

Recall of Harry London Chocolate Pecan Caramel Stars

Harry London today announced it is voluntarily recalling 3310 individual units of the 4.62 ounce Harry London Chocolate Pecan Caramel Stars because they have not been labeled to include Wheat, FD&C colors Yellow #5, Red # 40 and Blue #1 as an ingredient. All Harry London Chocolate Pecan Caramel Stars sold after 28 December 2009 have the correct labeling.

No illnesses or injuries have been reported to date. Harry London discovered the error during a routine quality control process check. The product is produced with a Pecan flavored wheat germ nut that is made with wheat and FD&C colorings, which were not stated in the ingredient disclosure label.

Although in all cases the package has an allergen statement indicating the product was manufactured on equipment shared with peanuts, tree nuts, soybeans, milk, eggs, and wheat, Harry London is undertaking this voluntary recall out of an abundance of caution. This voluntary recall does not affect any other products from Harry London.

The product being recalled is the Harry London Chocolate Pecan Caramel Stars Lot code number 9238-1

Working in cooperation with FDA, Harry London will also issue an alert through The Food Allergy and Anaphylaxis Network (www.foodallergy.org). Anyone who has the identified product with this Lot code in their possession should be aware of this Alert and take appropriate measures. Consumers affected by this Alert should avoid consumption and destroy the product. Consumers with questions may contact Harry London at (330) 494-0833 ext. 193, Monday through Friday, 8:30 A.M. – 5:00 P.M. EST.

Harry London apologizes for any inconvenience this may cause our valued customers; product quality and consumer safety have always been our top priority.

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Jan. 5, 2010

Drug Alert: Amiodarone Hydrochloride 50 mg/ml Concentrate

Aurum Pharmaceuticals
Amiodarone Hydrochloride 50 mg/ml Concentrate
PL 12064/0123

Batch Number Expiry Date Pack Size First Distributed
80593 09/2010 10 ampoules 30/10/2008
80604 12/2010 10 ampoules 17/4/2009

Following our Class 4 Caution in Use notice issued on 23 December 2009 (EL (09)A/36) and further discussions with Aurum Pharmaceuticals, all remaining stock of the above two batches is now being recalled from hospitals, wholesalers and relevant clinics.

For medical information enquiries please contact Aurum Pharmaceuticals medical information on 01708 382791. For enquiries relating to stock returns and credit please contact Aurum Pharmaceuticals customer services on 0800 028 7933.

Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter. Primary Care Trusts are asked to forward this to listed recipients, and relevant clinics and not to GP's and Community Pharmacists unless known to be relevant.

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Jan. 4, 2010

Iodine Warning on Bonsoy Soya Milk

Product:
Bonsoy Soya Milk

Batch Code:
All Best Before dates up to and including 03.11.11

Country Of Origin:
Japan

Message:
The Food Safety Authority of Ireland has been informed that Bonsoy soya milk from Japan has been implicated in thyroid illnesses in Australia due to a high level of iodine in the soya milk. The same soya milk has been distributed to Ireland in 1 Litre tetra packs. Following a recall of the product by food safety authorities in Australia and New Zealand, Irish distributors and suppliers of Bonsoy are currently being contacted to ensure that all affected product is withdrawn from sale and point of sale notices are displayed. The FSAI is continuing to monitor this recall.

Nature Of Danger:
Bonsoy soya milk is enriched with a seaweed product that naturally contains iodine, but the levels of iodine in the Bonsoy soya milk are too high. Iodine is an essential element required to make thyroid hormones, however, if consumption levels exceed tolerable daily intakes, the thyroid function may be affected.

Consumers:
Consumers who have the implicated product are advised not to drink it and to dispose of it or return it to the store where it was purchased. Consumers who have already consumed the product and are feeling unwell should seek medical advice.

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Jan. 4, 2010

Retail List of Recalled Ham Products

FSIS has reason to believe that the following retail location(s) received SUPER TRIM, Shurfine, IMPORTED, COOKED HAM, WATER ADDED, 98% FAT FREE products that have been recalled by Associated Grocers of Maine. This list may not include all retail locations that have received the recalled product or may include retail locations that did not actually receive the recalled product. Therefore, it is important that you use the product-specific identification information, available at Associated Grocers of Maine is Recalling Ham Products, in addition to this list of retail stores, to check meat or poultry products in your possession to see if they have been recalled.

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Jan. 3, 2010

Woolworth's Essentials Travel Hair Dryer

Product Description:
Woolworth's Essentials Travel Hair Dryer

Identifying Features:
Model no : 1204

Hazards:
Potential electrical shock and/or fire

Defects:
Faulty electrical switch within the handle which could pose the potential risk of electric shock or fire.

Dates Available For Sale:
* September 2009 - December 2009

Where Product Was Sold:
* National

Traders Who Sold Product:
Woolworth's / Safeway Supermarkets

Supplier:
Woolworth's Supermarkets

Comments:
Cease use immediately and return to a Woolworth's/ Safeway supermarket for a full refund

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Jan. 1, 2010

Recall of Butter Toffee Peanuts and Yogurt Covered Peanuts

Nutty Guys in cooperation with the U.S. Food and Drug Administration is issuing a voluntary recall of all:

  • Butter Toffee Peanuts and Yogurt Covered Peanuts with sell by dates before March 15th 2010

Insects were discovered in some of these products. If you have affected Nutty Guys Products with a sell by date of March 15 2010 or earlier, please contact Nutty Guys for instructions and refund.

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Jan. 1, 2010

Allergy Alert on Pecans in Publix Pumpkin Pecan Streusel Pie

Publix Super Markets is issuing a voluntary recall for Publix Pumpkin Pecan Streusel Pie, because it was mislabeled and may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of allergic reaction if they consume this product. Product was prepared at Publix stores for retail sale between November and December 2009.

The recalled product has a UPC number of: 002- 95118-20399-7 and is packaged in a 30 ounce plastic container. The name of the product describes the product as "Pumpkin Pecan Streusel Pie". The ingredient statement on the label does not declare pecan, which is an ingredient in the pie. The mislabeled pies were distributed in:

  • Alabama
  • Florida
  • Georgia
  • Tennessee
  • South Carolina

"As part of our commitment to food safety and in cooperation with the FDA, we are issuing this voluntarily recall," said Maria Brous, Publix director of media and community relations. "Since customers may still have these pies in their homes, we wanted to take every precaution to make them aware of the pecan as an ingredient. To date, there have been no reported cases of illness. Consumers who have purchased the product in question may return the product to their local store for a full refund. Publix customers with additional questions may call our Consumer Relations department at 1-800-242-1227 or by visiting our website at www.publix.com.

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 USDA Recall Classifications
Class I This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.
Class II This is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.
Class III This is a situation where the use of the product will not cause adverse health consequences.
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