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 ALERTS, NEWS, PRODUCT RECALLS

Medical Alerts, Medical News and Product Recalls for:

  • Australia
  • Canada
  • Ireland
  • New Zealand
  • United Kingdom
  • United States

  DATE  ALERTS, NEWS, RECALLS
Feb. 27, '10
Feb. 26, '10
Feb. 25, '10
Feb. 23, '10
Feb. 20, '10
Feb. 19, '10
Feb. 18, '10
Feb. 17, '10
Feb. 15, '10
Feb. 13, '10
Feb. 12, '10
Feb. 11, '10
Feb. 10, '10
Feb. 9, '10
Feb. 5, '10
Feb. 4, '10
Feb. 2, '10
Feb. 1, '10

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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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Feb. 27, 2010

Mithaighar Sweetened Yoghurt Recalled

Euroversal International/Mithaighar has recalled all of its Mithaighar Sweetened Yoghurt, because it was produced on premises that were served with a Hygiene Emergency Prohibition Order and a Remedial Action Notice by the local authority for that area because of poor food hygiene.

The Agency has issued a Food Alert for Information.

Euroversal International/Mithaighar has recalled the product and will display point-of-sale notices in shops that sell the yoghurt, explaining to customers why the product has been recalled and advising that customers shouldn't eat the yoghurt and should return it to the shop.

The recalled product is:

  • Mithaighar Sweetened Yoghurt (Doi)
    All 'use by' dates up to and including 7 March 2010
    Pack size: Small, medium, large

No other Euroversal International/Mithaighar products are known to be affected.

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Feb. 27, 2010

Pro-Pak Foods Recalls Some Sliced Chicken Roll

Pro-Pak Foods has recalled some of its two sliced chicken roll products, because they are contaminated with listeria. The products are Country Store Chicken Roll and Netto Chicken Roll. Listeria is a bacterium that causes food poisoning. The Agency has issued a Food Alert for Information.

Pro-Pak Foods has carried out a product recall and will be displaying point-of sale-notices in shops that sell either of the products, explaining to customers why the products have been recalled. If you have bought an affected product you can get a full refund.

The products are distributed in:

  • England
  • Scotland
  • Wales

But not Northern Ireland

The recalled products are:

  • Country Store Chicken Roll
    Pack size: 125g
    'Use by' dates: 28 February 2010, 2 March 2010, 7 March 2010, 8 March 2010, 9 March 2010 and 14 March 2010

  • Netto Chicken Roll
    Pack size: 400g
    'Use by' dates: 27 February 2010, 4 March 2010, 6 March 2010, 7 March 2010, 9 March 2010, 12 March 2010

No other Pro-Pak Foods products are known to be affected.

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Feb. 27, 2010

Johnny's French Dip Powdered Au Jus Recalled

Tacoma, WA - Johnny's Fine Foods of Tacoma, Wash., Johnny's Fine Foods is recalling French Dip Powdered Au Jus in 6oz bottles and French Dip Powdered Au Jus in 1.1oz foil packets, because it has 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.

To date no known illnesses have been associated with this product.

Johnny's French Dip Powdered Au Jus is distributed nationwide and is sold in retail stores.

  • Johnny's French Dip Powdered Au Jus 6oz is packaged in a clear plastic bottle with a red, white and blue label. The expiration date for this product is 0332. Johnny's French Dip Powdered Au Jus 1.1oz is packaged in a red, white and blue foil packet. The expiration date for this product is 02212.

The product was made using hydrolyzed vegetable protein manufactured by Basic Food Flavors, Inc. Las Vegas, Nevada. Basic Food Flavors initiated a recall of the hydrolyzed vegetable protein due to Salmonella contamination.

This product should be destroyed immediately. Consumers with questions may contact Johnny's Fine Foods at 1-800-962-1462 Monday thru Friday 8am to 3pm Pacific Standard Time.

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Feb. 27, 2010

American Pecan Co. Recalls Pecans

American Pecan Co. of Yancey, Texas, is recalling 1 lb. bags of Pecan Pieces, small, medium, and large sizes, because they have the potential to be contaminated with Salmonella, 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 1 lb. bags of pecans were sold to walk-up customers at

  • their Yancey, Texas location
  • as well as to mail order customers in
    • Texas
    • New York
    • Massachusetts

The bagged pecans consist of Ziploc-type bags labeled with "PECAN PIECES (Small, Medium, or Large) Ingredients: Shelled Pecans: Repacked by: American Pecan Co. P.O. Box 151 Yancey, Tx. 78886 Net weight 1-Lb. (16 oz.) 454 g. Might contain Pecan shells.." There are no codes associated with the products. No illnesses have been reported to date.

The recall was as the result of a routine sampling by the Food and Drug Administration, which revealed that the finished products contained the bacteria. The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.

Consumers who have purchased 1 lb. bags of PECAN PIECES are urged to dispose of the products and contact Mr. Rey Elizondo at American Pecan Co. for further instructions at 1-800-364-9053. Mr. Elizondo will be available 9:00 A.M. to 5:00 P.M., CST, Monday thru Friday.

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Feb. 26, 2010

Thumb Oilseed Recalls Soy Grits and Flour

Thumb Oilseed Producers' Cooperative of Ubly, MI. has recalled certain shipments of soybean grits and flour because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young c hildren, 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.

No illnesses have been reported to date.

The recalled soybean grits and flour were distributed to a limited group of wholesale customers located around the nation. These customers have been contacted by Thumb Oilseed and are reviewing this inventories and production processes and taking the necessary steps to protect consumer health, including, if necessary, sub recalls.

The product is labeled with Soy Beginnings or Nexsoy brands; packaged in 40# paper bags. Feed is packaged in 1500# totes. (Lot numbers include TF121608 through TF012210, TG121608 through TG010510).

The recall resulted from routine sampling programs conducted by the company and its wholesale customers. Thumb Oilseed has suspended production and distribution of the potential affected products and is cooperating with the US Food and Drug Administration and Michigan Department of Agriculture in investigating the situation.

The recall does not involve soy oil products produced by Thumb Oilseed.

Consumers with questions may contact the company at 989-658-2344 between 9:00 am and 4:00 pm EST Monday-Friday.

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Feb. 26, 2010

OneTouch® SureStep® Test Strips Recalled

LifeScan, Inc. is conducting a voluntary recall in the United States of eight lots of OneTouch® SureStep® Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

The eight lots of consumer OneTouch SureStep Test Strips being recalled are:

Recalled Lot Size Description
2969251 100-ct OneTouch SureStep
2969798 100-ct OneTouch SureStep
2982369 100-ct OneTouch SureStep
2983467 100-ct OneTouch SureStep
2969795 50-ct OneTouch SureStep
2982566 50-ct OneTouch SureStep
2969481 50-ct Medicare/Mail Order
2998193 50-ct Medicare/Mail Order

Lot #'s are located on the outer carton and test strip vial.

Patients with test strips from the recalled lots are asked to call LifeScan at 800 5 74-6139 between 5:00 am and 7:00 pm Pacific Time, seven days a week or visit www.SureStep.com to request replacement product. Replacement product will be shipped immediately and provided free of charge.

While waiting for replacement product to arrive, it is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher.

LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.

No injuries associated with these recalled test strips have been reported. However, if patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. Patients with high blood glucose may or may not have certain symptoms including increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision and fatigue (weak, tired feeling). High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

Hospitals, clinics and other multi-patient facilities using SureStep®Pro®, SureStep®Flexx® or OneTouch® SureStep® Hospital Systems have also been notified of this issue. All three of these systems use SureStep®Pro® Test Strips which also may provide inaccurately low test results when the blood glucose reading is greater than 400 mg/dL. LifeScan has advised these facilities of the appropriate actions to take in order to continue to use these SureStepPro Test Strips. However, healthcare facilities with access to alternative means of testing should consider temporarily discontinuing their use of their SureStep Systems until replacement test strips are available.

This field action is limited to eight lots of OneTouch SureStep Test Strips sold for consumer use in the U.S., and select SureStepPro Test Strips used in healthcare facilities. Similar recall actions are being taken in other countries where the affected product was distributed.

In 2006 LifeScan stopped selling OneTouch SureStep Meters in the U.S. but continued to provide test strips. Today, OneTouch SureStep Meter users represent a very small portion LifeScan's total customer base. The vast majority of LifeScan's customers now use OneTouch® Ultra® Brand Meters, which use an entirely different technology.

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Feb. 25, 2010

Wholesome Spice Recalls 25 Lb. Boxes Of Crushed Red Pepper

Wholesome Spice of Brooklyn, NY is recalling all lots of 25 lb boxes of Crushed Red Pepper sold between 4/6/09 and 1/20/10, because they have the potential to be contaminated with Salmonella, 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 25 lb boxes of Crushed Red pepper were distributed in the Northeastern U.S.. The product was not sold on the retail level to consumers.

  • The Crushed Red Pepper product is packaged in a clear plastic bag which is placed inside of a cardboard box with an adhesive white label with a blue border and blue and black lettering. The brand name on the product labels is WHOLESOME SPICES. The product name is listed as CRUSHED RED PEPPER.

It cannot be determined at this time if this product has been related to any illnesses to date.

The firm was informed that samples of its product have tested positive for Salmonella. The firm is currently working with the FDA to determine how the contamination occurred.

Manufacturers who have purchased 25 lb boxes of WHOLESOME SPICES brand Crushed Red Pepper are urged not to use the product and to recall any product they further distributed. Manufacturers with questions may contact the firm via telephone at (718) 388-1549. Our hours of operation are from Monday to Friday 8:30-4:30pm Eastern Standard Time.

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Feb. 25, 2010

Trader Joe's Recalls Chocolate Chip Chewy Coated Granola Bars

Trader Joe's Company of Monrovia, California is voluntarily expanding the recall of:

  • Trader Joe's Chocolate Chip Chewy Coated Granola Bars (SKU 82818) - ALL code dates, manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings, Inc.

This product has the potential to be contaminated with Salmonella, 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, 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 product involved in this recall was distributed at Trader Joe's stores nationally and comes in a 7.4 oz box. Production of the product has been suspended while FDA and Bloomfield Bakery continue their investigation.

No illnesses have been confirmed to date in connection with this product.

Customers who have purchased Trader Joe's Chocolate Chip Chewy Coated Granola Bars are urged to return them to any Trader Joe's for a full refund. Customers with questions may contact Trader Joe's Customer Relations Monday through Friday, 6am to 6pm PST at (626) 599-3817.

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Feb. 23, 2010

Berry Light Cereal Healtheries Simple Recalled

Package Description & Size:
320g

Identification:
Best before date 05 02 11 107

NZ Distribution:
Supermarkets and Health food Stores throughout North Island

Reason for Recall:
Bircher Apple and Raisin Muesli which contains gluten has been wrongly packed into Healtheries Simple Berry light Cereal boxes. Healtheries Simple Berry Light cereal is a wheat and gluten free product

Comments:
If you are wheat or gluten intolerant or a celiac, the product must not be consumed. There have been no reports of illness, however any person concerned about their health should seek medical advice. Customers should return the product to their retailer for a full refund or phone 0800 848 254 with any queries. This recall does not affect any other Vitaco Health (NZ) Limited or Healtheries products.

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Feb. 20, 2010

Organic Peanut Crunch, Dutch Apple And Wildberry Chewy Granola Bars Recalled

Lovin Oven, LLC of Irwindale, CA announced that it has taken the precautionary measure of voluntarily recalling certain Health Valley Organic Peanut Crunch, Dutch Apple and Wildberry Chewy Granola Bars because they have the potential to be contaminated with Salmonella.

The bars contain organic toasted soy grits supplied by Thumb Oilseed Producers Cooperative of Ubly, MI which is the subject of an FDA investigation concerning recent Salmonella outbreaks. No illnesses have been reported in connection with the recalled bars and no other types of Health Valley brand bars are being recalled.

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 Peanut Crunch, Dutch Apple and Wildberry chewy granola bars are distributed nationally. The only lots affected are:

6.1oz HV ORG PEANUT CRUNCH 6.1oz HV ORG DUTCH APPLE 6.1oz HV ORG WILDBERRY
07DEC09H2 03JAN10H1 05JAN10H2
15JAN10H2 05FEB10H2 15JAN10H1
23FEB10H2 05FEB10H2 12APR10H1
28FEB10H2 28MAR10H2 06JUL10H1
28MAR10H2 17AUG10H1 08MAR10H1
29MAR10H1
13APR10H1
06SEP10H2
06NOV10H2
09FEB10H2

Product Description and SKU (number on bottom used to scan at checkout)

  • Health Valley Organic Peanut Crunch Chewy Granola Bars, 6.1 oz box, #0-35742-15483-4
  • Health Valley Organic Dutch Apple Chewy Granola Bars, 6.1oz box, #0-35742-15487-7
  • Health Valley Organic Wildberry Chewy Granola Bars, 6.1oz box, #0-35742-15481-0

Consumers who have purchased any products covered by this recall are urged to return them to the store of purchase for a full refund. Consumers with questions or concerns about the recall may call the hotline at 1-800-423-4846 (7:00 AM – 5:00 PM Mountain Time). Consumers with questions or concerns about their health should contact their doctor.

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Feb. 20, 2010

Queseria Bendita Recalls Queso Fresco, Panela, and Requeson

Queseria Bendita ofYakima, Wash., is recalling three types of cheese:

  • Queso Fresco
  • Panela
  • Requeson

Because they have the potential to be contaminated with Listeria monocytogenes, an organism that 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, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The Queso Fresco, Panela, and Requeson cheeses are sold at Queseria Bendita's retail store and were distributed in Washington and Oregon, where they are sold in Hispanic markets.

The Queso Fresco is packaged in one and three-pound vacuum packed wheels; the Panela is vacuum packed in one and three pound sizes; and the Requeson is packed in eight-ounce and one pound clear plastic tubs.

Each cheese has a green label identifying the type of cheese, the Queseria Bendita brand name, and a date code up to and including "Apr 30 2010".

To date there is one confirmed illness in Washington related to the recalled product. Other illnesses in Washington and Oregon may also be related.

The public health investigation of the illnesses led to sampling and testing of the cheeses. The testing revealed the contamination of the product with Listeria monocytogenes.

The company has ceased production and distribution of the product while the Washington State Department of Agriculture, the U.S. Food and Drug Administration, and the firm investigate the source of the problem.

Consumers who have purchased the product are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-509-574-8587 Monday through Friday between 9 a.m. and 5 p.m.

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Feb. 19, 2010

Unauthorized OM Fusion Distributors LLC Health Products Found on Canadian Market

Health Canada is warning consumers of unauthorized health products sold under the OM Fusion Distributors LLC label included in the table below. The use of these products may cause life threatening reactions. There are serious risks with taking unauthorized drugs without supervision by a health care professional. If you take these products, you may also prevent your physician from properly diagnosing your condition and prescribing the correct medication.

Canadians who have purchased or used these products bearing the OM Fusion label are advised to immediately consult a health care practitioner. Consumers are advised to monitor the Health Canada Web site for additional updates regarding this issue.

The manufacturer packaging for the seven unauthorized products list certain ingredients that are drugs. These ingredients should only be sold with a prescription and are intended for use under the supervision of a health care professional only. It is illegal to sell to the public a product containing these ingredients unless the sale is made pursuant to a prescription.

The OM Fusion Distributors LLC label appears as a white sticker on top of the standard manufacturer packaging and falsely represents the prescription drugs as natural health products, such as skin care cream and dietary supplements.

Unauthorized Health Product Reported Drug Ingredient(s)
Adelphane – Esidrex Hydrated Dihydralazine Sulphate
Antihemorroi Ointment Betamethasone Valerate
Erythromycin Erythromycin
Ftorocort Triamcinolone Acetonide
Levomycetin Chloramphenicol
Prednisolonum Prednisolonum
Zdorovye Ampicillin

Consumers should exercise caution when purchasing health products. 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 reminds retailers that the sale of unauthorized drugs contravenes the Food and Drugs Act. Sale of unauthorized drugs could render the seller liable for conviction for an offence under the Act. As such, Health Canada advises retailers to remove these products from their shelves and contact the Health Products and Food Branch Inspectorate for more information.

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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Feb. 19, 2010

Fresh & Easy Chewy Chocolate Chip Granola Bars Recalled

Fresh & Easy Neighborhood Market Inc., is voluntarily recalling all date codes of Fresh & Easy™ Chewy Chocolate Chip Granola Bars as a result of a recall initiated by Thumb Oilseed Producers. This company supplies an ingredient that has 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.

This is the only Fresh & Easy product affected and there have been no illnesses reported.

  • Fresh & Easy™ Chewy Chocolate Chip Granola Bars - 6count/7.4oz carton - CODE#: 5051379001377 - ALL Dates

The recalled products were sold in Fresh & Easy Neighborhood Market stores located in California, Nevada, and Arizona.

Customers may return the unused product, empty product containers or present the receipt as proof of purchase of the recalled product to any Fresh & Easy store for a full refund. Consumers who have questions or concerns about this recall should contact the Fresh & Easy 24-hour toll free number at 1 (800) 648-8622.

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Feb. 18, 2010

FDA Announces New Safety Controls for Medications Used to Treat Asthma

The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

These new requirements are based on FDA analyses of clinical trials showing that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma. The drugs involved include:

  • single agent products Serevent and Foradil
  • combination medications Advair and Symbicort that also contain inhaled corticosteroids.

These medications improve a patient's ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung's airways.

The FDA will now require that the product labels reflect the following:

  • The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid. Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone;

  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;

  • LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.

  • Pediatric and adolescent patients who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.

"Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death," said Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products in the FDA's Center for Drug Evaluation and Research.

"The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone," said Dianne Murphy, M.D., director of the FDA's Office of Pediatric Therapeutics.

LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma.

The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, FDA will work with public and private partners under the agency's ongoing Safe Use Initiative to study LABA prescribing practices.

"We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don't adjust, we will determine the reasons and consider additional steps to support safe prescribing," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.

  • Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline
  • Foradil is marketed by Lebanon, PA-based Novartis AG
  • Symbicort is marketed by Wilmington, DE-based AstraZeneca

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Feb. 17, 2010

FDA Warns about Serious Side Effects from Maalox Product Mix-Ups

The U.S. Food and Drug Administration today warned consumers about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the relief of different symptoms and contain different active ingredients.

Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids. Both Maalox Total Relief and Maalox are made by Novartis Consumer Health Inc. (NCH) and are available without a prescription as over-the-counter liquid medications. The maker of Maalox brand products has agreed to change the name of Maalox Total Relief to one that does not include the word "Maalox" and will change the drug's packaging to avoid further confusion.

"Maalox Total Relief and Maalox are not interchangeable and shouldn't be used in place of each other," says Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis. "Consumer confusion and incorrect product use due to name confusion are serious public health issues. We appreciate Novartis' efforts to work collaboratively with FDA and their decision to remedy this situation to avoid any confusion over Maalox products in the future."

Maalox Total Relief's active ingredient (bismuth subsalicylate) is chemically related to aspirin and may cause similar harmful side effects such as bleeding. As such, Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder.

Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.

Packaging and labeling of Maalox Total Relief and traditional Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are very similar and easily confused. Due to this confusion, NCH has agreed to:

  • Change the name of Maalox Total Relief to one that does not include the root name Maalox as well as change the product label design;

  • Conduct an educational campaign with outreach to healthcare professionals and consumers regarding different Maalox products and ways to select the appropriate Maalox brand product; and

  • Actively monitor and report adverse events associated with the use of Maalox brand products.

"The FDA is concerned about the public health impact of medication mix-ups for products that have the same names or portions of the same name, but contain different active ingredients," said Ms. Holquist. "We want companies to consider the potential for name confusion when choosing names for their drugs."

The renamed product is expected to begin selling in September 2010. Until that time, FDA is advising consumers and healthcare professionals to carefully check the labels of all Maalox products to ensure the appropriate product is being selected for the patient's symptoms.

Any Maalox side effects or other product problems should be reported to FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-332-1088.

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Feb. 17, 2010

Estrella Family Creamery Expands Recall Of Various Cheeses

Estrella Family Creamery of Montesano, WA is recalling:

  • Brewleggio
  • Domino
  • Wynoochee River Blue cheeses

Because they have the potential to be contaminated with 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, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The products were sold to restaurants and cheese shops in WA, OR, and NJ.

  • The Domino cheese is a one pound, natural rind wheel made from cow's milk

  • The Brewleggio cheese is a soft washed rind cow's milk wheel 8" wide by 2" tall, weighing approximately 3 pounds

  • The Wynoochee River Blue Cheese is a 5 pound wheel with a rustic natural rind, blue veined.

The products are not coded. No illnesses have been reported to date.

The recall, which initially included Red Darla cheese, has now been expanded to include Domino Cheese that also tested positive for Listeria monocytogenes. Brewleggio and Wynoochee River Blue cheeses are also being included in the expanded recall because they were aged in the same room as the Domino cheese. The company has ceased the production and distribution of the products as the Washington State Department of Agriculture, the Food and Drug Administration, and the company continue their investigation as to what caused the problem.

Consumers can return any remaining product to the place of purchase for a full refund. Any questions can be answered by Kelli or Anthony at the Creamery, 360.249.6541, Monday – Friday, 6:00am – 8:00pm PST.

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Feb. 17, 2010

Retail List for Recalled Beef Products

FSIS has reason to believe that the following retail location(s) received beef and veal products that have been recalled by Huntington Meat Packing 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 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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Feb. 17, 2010

Daniele International Expands Recall 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 115,000 pounds of salami/salame products 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 tested by FSIS, and by ingredient testing performed by the company. The product was sampled during the course of an ongoing investigation of a multi-state outbreak of Salmonella serotype Montevideo illnesses. These products were not subject to recall previously because they are not sausage products that contain black pepper on the external surface, or packaged with such products. Based on preliminary testing results, the company believes that crushed red pepper may be 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 but the investigation is ongoing and the root cause of the contamination has not yet been determined.

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:

  • 8-ounce packages of "DANIELE HOT SALAME PANINO WITH FRESH MOZZARELLA."

  • 8-ounce packages of "BOAR'S HEAD SALAME PANINO, SALAME ROLLED IN MOZZARELLA CHEESE."

  • 8-ounce packages of "DANIELE ITALIAN STYLE SALAME PANINO, HOT SALAME ROLLED IN MOZZARELLA CHEESE."

  • Random weight packages of "DANIELE ITALIAN STYLE SALAME PANINO, HOT SALAME ROLLED IN MOZZARELLA CHEESE."

  • 8-ounce packages of "DIETZ & WATSON ARTISAN COLLECTION HOT SALAME PANINO, HOT SALAME ROLLED IN MOZZARELLA CHEESE."

  • 8-ounce packages of "DANIELE SALAME PANINO WITH FRESH MOZZARELLA AND BASIL."

  • 1-pound 8-ounce variety packages of "DANIELE CAPOCOLLO PANINO WITH FRESH MOZZARELLA AND BASIL; PRESIDENT'S PROSCIUTTO PANINO WITH FRESH MOZZARELLA AND BASIL; HOT SALAME PANINO WITH FRESH MOZZARELLA," with UPC Code 736436709582. NOTE: The products contained in this variety three-pack may be sold individually as well.

Each package bears a label with establishment number "EST. 459" inside the USDA mark of inspection. The above products are sold individually packed, except as noted above. The products subject to recall have sell-by dates ranging from February 3, 2010, through May 26, 2010, and 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.

Consumers with questions about the recall should contact the company's Hotline at (888) 3 45-4160. Media with questions about the recall should contact the company's public relations contact, Levick at (202) 973-1335.

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Feb. 15, 2010

Drug Alert: Citanest 1% Solution

AstraZeneca UK Ltd
Citanest 1% solution for injection multi-dose vials 10mg/ml
Prilocaine Hydrochloride
PL 17901/0118

AstraZeneca UK Ltd is recalling all remaining stock of batches of the above product expiring before the end of 2011. This action is being taken because routine stability testing has indicated that the preservative levels may become too low after 24 months from manufacture.

A list of the batches to be recalled is included below.

For medical information enquiries please contact AstraZeneca UK medical information on 0800 783 0033. Any affected batches should be returned via its agents - AAH Pharmaceuticals or Alliance Healthcare where credit will be issued. For any further stock enquiries please contact AstraZeneca UK Supply Chain Team on 0800 032 0501.

List of 12 batches of Citanest 1% Solution for injection Multi-dose vials 10mg/ml to be recalled:

Batch Number Expiry date Pack size First distributed
FX337 2/12/2011 1X50ML  March 2009
FS216 30/6/2011 1X50ML   January 2009
FP186 29/5/2011 1X50ML  December 2008
FM069 19/5/2011 1X50ML  October 2008
FJ545 26/3/2011 1X50ML  August 2008
FF738 14/12/2010 1X50ML  May 2008
FD238 11/12/2010 1X50ML  March 2008
FA944 5/9/2010 1X50ML  January 2008
EY517 28/8/2010 1X50ML  November 2007
EX030 25/7/2010 1X50ML  October 2007
EV669 2/5/2010 1X50ML  October 2007
EV050  2/5/2010 1X50ML  August 2007

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Feb. 13, 2010

Hellers Sensational Chinese Honey Sausages Recalled

Name of Product:
Hellers Sensational Chinese Honey Sausages

Package Description & Size:
1kg

Identification:
Use by date 180310

NZ Distribution:
On sale in Supermarkets throughout North Island since 05 February 2010

Reason for Recall:
Incorrect labelling and product contains dairy allergens. The product is actually Chunky cheese sausages which have been incorrectly packaged as Chinese honey

Comments:
There have been no reports of illness, however any person concerned about their health should seek medical advice. Customers should return the product to their retailer for a full refund or phone 0800 HELLERS with any queries. This recall does not affect any other Hellers products.

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Feb. 13, 2010

Huntington Meat Packing Expands Recall on Beef Products

Huntington Meat Packing Inc., a Montebello, Calif., establishment, is expanding its recall of January 18 to include approximately 4.9 million additional pounds of beef and veal products that were not produced in accordance with the company's food safety plan. The products are adulterated because the company made the products under insanitary conditions failing to take the steps it had determined were necessary to produce safe products, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. FSIS has received no reports of illnesses associated with consumption of these products. Individuals concerned about an illness should contact a physician.

The recall was expanded based on evidence collected in an ongoing criminal investigation being conducted by the Office of the Inspector General (OIG) with assistance from FSIS. This evidence shows that the products subject to this recall expansion were produced in a manner that did not follow the establishment's Hazard Analysis and Critical Control Points (HACCP) plan. A HACCP plan describes the process controls an establishment must take to prevent food safety hazards and create a safe and wholesome product. The investigation has uncovered evidence to show that the food safety records of the establishment cannot be relied upon to document compliance with the requirements. Therefore, FSIS must consider the products to be adulterated and has acted to remove the products from commerce.

The following beef and veal products, produced by the plant from January 22, 2009, to January 4, 2010, are subject to recall:

  • 10 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
  • 10 lb. boxes of "El Rancho MEAT & PROVISION ALL BEEF PATTIES"
  • 20 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
  • 50 lb. boxes of "HUNTINGTON MEATS GROUND BEEF"
  • 50 lb. boxes of " HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING"
  • 50 lb. boxes of "BEEF BURRITO FILLING MIX"
  • 50 lb. boxes of "HUNTINGTON MEAT PKG. INC. DICED BEEF"
  • 50 lb. boxes of "HUNTINGTON MEAT PKG. INC. SLICED BEEF"
  • 10 lb. boxes of "Huntington Meat VEAL PATTY"
  • 10 lb. boxes of "Imperial Meat VEAL PATTY"
  • 10 lb. boxes of "El Rancho VEAL PATTY"
  • 20 lb. boxes of "Huntington Meat VEAL PATTY"
  • 20 lb. boxes of "Imperial Meat VEAL PATTY"
  • 20 lb. boxes of "El Rancho VEAL PATTY"

Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on a label. The products were produced between January 22, 2009, and January 4, 2010, and were shipped to distribution centers, restaurants, and hotels within the State of California.

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.

Media and consumer questions regarding the recall should be directed to the company Owner Robert Glenn at (323) 726-9714.

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Feb. 12, 2010

Recall On Nature's Variety Raw Frozen Chicken Diets

Nature's Variety has initiated a voluntary recall of their Chicken Formula Raw Frozen Diet for dogs and cats with a "Best If Used By" date of 11/10/10 because these products may be contaminated with Salmonella. The only products affected are limited to chicken medallions, patties, and chubs with a "Best If Used By" date of 11/10/10. No other Nature's Variety products are affected.

The affected products are limited to the Nature's Variety Chicken Formula Raw Frozen Diet packaged in the following forms:

  • 3 lb chicken medallions (UPC# 7 69949 60130 2) with a "Best If Used By" date of 11/10/10
  • 6 lb chicken patties (UPC# 7 69949 60120 3) with a "Best If Used By" date of 11/10/10
  • 2 lb chicken chubs (UPC# 7 69949 60121 0) with a "Best If Used By" date of 11/10/10

The "Best If Used By" date is located on the back of the package above the safe handling instructions. The affected product was distributed through retail stores and internet sales in the United States, and in limited distribution in Canada.

If you are a consumer and have purchased one of the affected products, please return the unopened product to your retailer for a full refund or replacement. If your package has been opened, please dispose of the raw food in a safe manner by securing it in a covered trash receptacle. Then, bring your receipt (or the empty package in a sealed bag) to your local retailer for a full refund or replacement.

Nature's Variety became aware of a potential problem after receiving a consumer complaint. Subsequent testing indicated that the lot code related to the consumer complaint tested negative for Salmonella. However, additional subsequent testing found the "Best If Used By" date of 11/10/10 to be contaminated with Salmonella.

No pet or human illnesses have been reported to date in connection with this lot code.

Reed Howlett, Nature's Variety CEO, stated, "Because pet health and safety are our top priority, Nature's Variety takes every step necessary to ensure the quality and safety of our products. In addition to our industry best manufacturing practices, and in an abundance of caution, all Nature's Variety raw frozen products now will undergo a ‘test and hold' period before being released for sale."

Salmonella can affect both humans and animals. Even though no illnesses have been reported, consumers should follow the Safe Handling Guidelines published on the Nature's Variety package when disposing of the affected product. People handling raw frozen pet foods may become infected with Salmonella, especially if they have not followed the safe handling guidelines set forth by the company.

Healthy people infected with Salmonella may experience some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, or 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, or urinary tract symptoms. Consumers exhibiting these signs after having contact with the affected product should contact their health care provider.

Pets with Salmonella infections may become lethargic and have diarrhea or bloody diarrhea, fever, or vomiting. Some pets may experience only a decreased appetite, fever, or 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 products and is experiencing any of these symptoms, please contact your veterinarian.

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Feb. 12, 2010

Red Darla Cheese Recalled

The Estrella Family Creamery of Montesano, Washington, is recalling its Red Darla cheese because it has the potential to be contaminated with 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, nausea, abdominal pain and diarrhea, Listeria infections can cause miscarriages and stillbirths among pregnant women.

Red Darla cheese was sold in January 2010 through February 11, 2010 at:

  • the Ballard and Seattle's U-District farmer's markets
  • two Seattle restaurants
  • retail stores in the Seattle-Tacoma area
  • the firm's retail store in Montesano, Washington
  • a retail market in San Francisco, California
  • a cheese shop in Springfield, New Jersey

The recalled cheese is a soft cheese, 3/4 lb wheel, made of cow milk and washed in red wine while aging. The product does not contain a lot code.

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

The recall is the result of a routine sampling program by the state of Washington Department of Agriculture, which revealed that one wheel of the finished product contained the Listeria monocytogenes bacteria. Estrella Family Creamery has ceased production and distribution of the product as the FDA, WSDA, and the company continue investigating the cause of the problem.

Consumers who have any Red Darla should return the cheese to the place of purchase for a full refund. Consumers with questions may contact the company at 360.249.6541 between 6:00am – 8:00pm PST.

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Feb. 12, 2010

Trader Joe's Chocolate Chip Chewy Coated Granola Bars

Trader Joe's Company of Monrovia, California is voluntarily recalling:

  • Trader Joe's Chocolate Chip Chewy Coated Granola Bars, UPC 82818, Use by Dates/Lot Codes 16JUL10H2 and 17JUL10H1

Manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings, Inc. because it has the potential to be contaminated with Salmonella, 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, 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 product involved in this recall was distributed at Trader Joe's stores nationally and comes in a 7.4 oz box marked with Use by/Lot Codes 16JUL10H2 and 17JUL10H1 on the top of the box and stamped individually on the side of each granola bar. Production of the product has been suspended while FDA and Bloomfield Bakery continue their investigation.

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

At Trader Joe's we take the safety of our customers and the integrity of our products very seriously. Customers who have purchased Trader Joe's Chocolate Chip Chewy Coated Granola Bars, Use by/Lot Codes 16JUL10H2 and 17JUL10H1 are urged to return them to any Trader Joe's for a full refund. Customers with questions may contact Trader Joe's Customer Relations Monday through Friday, 6am to 6pm PST at (626) 599-3817.

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Feb. 12, 2010

Giant and Stop & Shop Recalls 24 oz. Party Platter Cookies

Giant Food of Landover, Md. and The Stop & Shop Supermarket Company have announced a voluntary recall of its 24 oz. Party Platter Cookies because they contain almonds and almond paste, undeclared allergens that pose a serious and potential life-threatening health risk to allergic individuals. Giant has removed from sale the following product:

  • Giant Food Party Platter Cookies
    UPC# 0200148262, 24 oz., all codes
  • Stop & Shop Party Platter Cookies
    UPC# 200055639, 24 oz. all codes

The product is packaged on a rectangular platter with a plastic overwrap and sold through Giant's In-Store Bakery and Stop & Shop In-Store Bakery.

To date, Giant has received no reports of illnesses associated with the consumption of this product. Customers who have purchased the product should discard any unused portions and bring their purchase receipt to any Giant supermarket for a full refund. Customers looking for additional information are encouraged to call Giant's corporate brands consumer line at (877) 846-9949 Monday through Friday from 9 a.m. to 4 p.m. Stop & Shop Customers who have purchased the product should discard any unused portions and bring their purchase receipt to any Stop & Shop supermarket for a full refund. Customers looking for additional information are encouraged to call Stop & Shop's corporate brands consumer line at 1-877-846-9949, Monday through Friday from 9am – 4pm.

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Feb. 11, 2010

Heinz Fruity Custard Fruit Medley Recalled

The public will wish to be aware that Heinz is recalling a certain batch and date code of Heinz Fruity Custard Fruit Medley baby food due to potential presence of small plastic pieces.

The implicated product mentioned below is being recalled. Point of sale notices will be displayed in those stores that stocked the affected product. These notices alert customers to the recall and advise them of what actions to take if they have purchased the product.

The product recalled is:

  • Heinz Fruity Custard Fruit Medley
    Plastic pouches 4x100g
    Batch code: 9307
    Best before: 03/11/10

No other Heinz products are known to be affected.

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Feb. 10, 2010

Ready-To-Eat Sausage Products Recalled

Schmalz European Provisions, a Springfield, N.J., establishment, is recalling approximately 1,485 pounds of ready-to-eat sausage products that may contain foreign materials, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The product subject to recall includes:

  • 12-ounce packages of "Applegate Farms CERTIFIED ORGANIC FIRE ROASTED RED PEPPER FULLY COOKED CHICKEN & TURKEY SAUSAGE." Each package also indicates "KEEP REFRIGERATED" and "SKINLESS" on the label.

Each package has a USE BY/FREEZE BY date of February 28, 2010 and "Heating Instructions" on the back of the label. Also, the products bear the establishment number "P-5411" inside the USDA mark of inspection. The products were produced on January 7, 2010 and were distributed to retailers in:

  • California
  • Connecticut
  • Florida
  • Georgia
  • Indiana
  • New Hampshire
  • New Jersey
  • New York
  • North Carolina
  • Ohio
  • Oregon
  • Texas

The problem was discovered after the company reported consumer complaints about finding plastic materials 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 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 Emily Colon, Quality Assurance Specialist, at (800) 587-5858. Media with questions about the recall should contact Gina Asoudegan, Public Affairs, at (800) 587-5858.

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Feb. 10, 2010

Frozen Cured Pork Patty Mix Recalled

Champ Meatball Co., a Whittier, Calif., establishment, is recalling approximately 750 pounds of frozen cured pork patty mix because it contains an undeclared allergen, wheat, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. Wheat is a known potential allergen, which is not declared on the label.

The product subject to recall includes:

  • 14-ounce packages of frozen "CHAMP, Nem Nuong Cured Pork Patty Mix for Barbecue Meat Balls." Each package bears the establishment number "EST. 21436" inside the USDA mark of inspection.

The frozen cured pork patty mix products were produced on various dates, and were distributed to retail establishments and restaurants in Arizona and California.

The problem was discovered by FSIS. FSIS and the company have 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 (including restaurants) of the recall and that steps are taken to make certain that the product is no longer available to consumers.

Consumer and media with questions about the recall should contact company Owner Krid Hansaward at (562) 693-7836.

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Feb. 10, 2010

'Complete 7-Day Cleanse' Recalled

Health Canada is advising consumers that the unauthorized product 'Complete 7-Day Cleanse' is being recalled because it contains a number of active ingredients with a combined effect that may pose serious health risks. 'Complete 7-Day Cleanse' is a multi-ingredient natural health product promoted for 'cleansing' or removing toxins from the body.

According to package labelling, the product contains over 30 active ingredients, some having a diuretic (water pill) or laxative (stimulant, and bulk-forming) effect. This combination of ingredients may increase the laxative or diuretic impact of the product and pose a risk of dehydration and/or electrolyte imbalance.

Symptoms of severe dehydration may involve an altered mental state and dizziness. Symptoms of moderate to severe electrolyte imbalance (which is an imbalance of salts in the body, such as potassium or sodium) may include muscle weakness or cramping, abnormal heartbeat, and difficulties breathing.

The product is available at retail outlets across Canada and over the Internet. The Canadian importer, Iovate Health Sciences International Inc., of Oakville, Ontario, has initiated a nationwide recall at the request of Health Canada.

Canadians who have used 'Complete 7-Day Cleanse' and are concerned about their health should speak to a health care practitioner. Individuals should be aware of signs or symptoms of dehydration or electrolyte imbalance, as described above.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label. This authorization indicates that the products have been assessed by Health Canada for safety, effectiveness and quality.

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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Feb. 9, 2010

Recall of IV Extension Sets with BD Q-Syte Luer Access Device

Acacia, Inc. (formally known as MPS Acacia) has voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. The BD Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company). Use of the affected BD Q-Syte™ Luer Access Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. This field corrective action included notification to customers worldwide by letter.

The IV Extension Set with BD Q-Syte™ Luer Access device is intended for use with other infusion therapy products in the administration of fluids into the intravenous system.

The following REF (catalog) and lot numbers, which were sold in the U.S., are included in the recall:

MPS Acacia IV Extension Set with BD Q-Syte

REF or Catalog Numbers:
  • 385150
  • 385151
  • 385164
  • 385165
  • 385166
Lot Numbers:
  • A1950
  • A1951
  • A1967
  • A1979
  • A2055
Lot Numbers:
  • A2056
  • A2099
  • A2100
  • A2101
  • A2104

Patient safety and the quality and safety of our products are Acacia's first priorities. The recall was initiated on Dec. 18, 2009 after Acacia received information from BD of complaints received due to air entry through the bottom disk of the Q-Syte™ septum. BD investigated and determined the root cause to be a manufacturing deviation. Though Acacia has not received any customer notification of product failures with the Acacia IV Extension Sets with BD Q-Syte™, product failures occurred with BD labeled devices that included BD Q-Syte™ units distributed from November 2008 through November 2009.

The root cause has been corrected by BD and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented.

The approximately 217,000 IV Extension Sets with BD Q-Syte™ that were recalled were distributed in the United States exclusively to BD for distribution worldwide, which includes the United States, Canada, Europe, Asia, Australia, and North and South American Countries.

Acacia has notified the U.S. Food and Drug Administration and other worldwide health agencies, as necessary, and is working with them to coordinate recall activities. Clinicians or distributors with questions can contact Acacia at 1-800-486-6677 between 8:00 AM and 5:00 PM Pacific Standard Time, Monday-Friday, or dial directly at 714-257-0470.

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Feb. 9, 2010

Turkey Hill Dairy Issues Recall On Chocolate Marshmallow Ice Cream

Turkey Hill Dairy of Conestoga, Pa., is recalling its:

  • 1.5 qt. (48 oz./1.42L) packages of Chocolate Marshmallow Premium Ice Cream

Because the product may contain almonds that were inadvertently added during production.

No illnesses have been reported to date in connection with this issue, although people who have allergies to almonds run the risk of serious or life-threatening allergic reactions if they consume these products. The product is safe for consumption by consumers without nut allergies.

The recalled Chocolate Marshmallow Premium Ice Cream is limited only to select stores in central Pennsylvania. All affected stores are directly delivered to and serviced by Turkey Hill Dairy and have been instructed to remove the product from their shelves.

The recall was initiated after it was discovered that the recalled product was distributed in packaging that did not identify almonds as an ingredient. It is believed that less than 150 containers of ice cream were potentially exposed to almonds. All affected containers would have been purchased by consumers after January 28, 2010

The product comes in a rounded, rectangular, cream-colored, paperboard, 48 oz. packages with farm scene and ice cream scoop graphics. The affected product is marked on the bottom of the package with the code "01/18/2011 56/L1". Preceding the code is a four-digit number indicating the production time. The recalled product includes a time between 02:25 and 02:35.

Consumers who have purchased affected 48 oz. packages of Chocolate Marshmallow Premium Ice Cream with the previously mentioned code can return them to the place of purchase for a full refund. Consumers with questions may contact Turkey Hill Dairy at 1-800-MY-DAIRY (1-800-693-2479).

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Feb. 4, 2010

Pork Barbecue Products Recalled Due to Undeclared Allergen

The Murphy House, a Louisburg, N.C., establishment, is recalling approximately 2,850 lbs. of pork barbecue products because they may contain an undeclared allergen, soy flour, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. Soy flour is a known potential allergen, which is not declared on the label.

The product subject to recall includes:

  • 5-lbs. buckets of "The MURPHY HOUSE PREMIUM PORK BARBECUE; COOKED, UNSKINNED, PORK WITH BARBECUE SAUCE ADDED" Each package bears the establishment number "EST. 2135" inside the USDA mark of inspection.

The pork barbecue products were sent to distributors and restaurants in the North Carolina region.

The problem was discovered during a routine review of operations by FSIS at the establishment. 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 Josh Whitely, Vice President, at (919) 496-6054.

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Feb. 4, 2010

Retail Distribution List Udated for Sausage Product Recall

A third update to the list of retail consignees has been posted for Daniele International Recalling Italian Sausage Products, Due to Possible Salmonella Contamination.

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Feb. 4, 2010

Recalled Italian Sausage Products (Update)

As part of the continuing investigation, this recall release is being updated on February 4, 2010, to include two additional products, adding approximately 23,754 pounds to the January 23 recall. It should be noted that these additional products are separate from those listed on the January 31 expansion.

The two additional products are:

  • 3-ounce packages of "DANIELE NATURALE SALAME COATED WITH COARSE BLACK PEPPER."
  • Approximately 6-pound packages of "DANIELE SALAME GRANDE COATED WITH PORK FAT & PEPPER."

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Feb. 4, 2010

Alert On Uneviscerated Whole Schmaltz Herring

Haifa Smoked Fish, located in Queens, New York, is recalling Haifa brand vacuum packaged Whole Schmaltz Herring with the lot number 20, because the product was found to be uneviscerated.

The lot being recalled is a product of Norway, individually vacuum-packed in clear plastic pouches with lot # 20 indicated on the label and distributed through various food retailers in the NY and NJ area.

The Whole Schmaltz Herring was sampled by a New York State Agriculture and Markets Food Inspector during a routine inspection. Subsequent analysis of the product by New York State Food Laboratory personnel confirmed that Whole Schmaltz Herring was not properly eviscerated prior to processing.

The sale of uneviscerated fish is prohibited under New York State Agriculture and Markets regulations because of Clostridium Botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Uneviscerated fish has been linked to outbreaks of botulism poisoning.

Botulism is a serious and 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.

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

Consumers are warned not to use the product even if it does not look or smell spoiled and should return it to the place of purchase. Consumers with questions may contact the company at 718-523-8899.

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Feb. 4, 2010

Dangers Related to Furniture, Television and Appliance Tip-Overs

Health Canada is advising parents and caregivers to take precautionary steps to help minimize the dangers related to television, furniture and appliance tip-overs. According to data from the Canadian Hospitals Injury Reporting and Prevention Program, there have been more than 5,000 reports of televisions, furniture and appliances falling over onto children under 10 years of age since 1990. Furniture or television tip-overs can cause serious head and internal injuries, as well as suffocation, which can lead to death. More than 70% of the reported television tip-over incidents in Canada happened to children between one and three years of age.

Common circumstances that can lead to tip-over incidents include children:

  • climbing on furniture, televisions or appliances
  • reaching for items such as toys or remote controls located on elevated surfaces
  • pushing, pulling or accidentally bumping into televisions or pieces of furniture

Take these simple steps to help minimize the danger in your home:

  • Always supervise children in the home and teach them not to climb on or hang from furniture.

  • Choose storage furniture, such as bookcases, cabinets, television stands, and dressers, with a wide and stable base that sits directly on the floor. Models with legs or wheels are more likely to tip-over.

  • Attach furniture to the floor or wall stud using the appropriate angle braces, anchors or safety straps. If these items come with the product, follow the manufacturer's instructions for installation.

  • Place televisions far back on low stable furniture that is designed to hold the weight and size of the television. Attach the television to the stand, if possible.

  • Keep electric cords behind furniture where children cannot reach them.

  • Do not place items that may appeal to a child, such as toys, plants and remote controls, on top of a television or tall furniture.

  • Do not place heavy items on top of elevated surfaces.

  • Regularly check that furniture, televisions and appliances are stable and secure and that electrical cords are out of children's reach.

  • For furniture with drawers, only open one drawer at a time to reduce the chance that it will tip over; completely close all drawers when not in use so they cannot be used as steps by a child; place heavier items in lower drawers; and install locking devices on each drawer if you have young children.

  • Do not assemble and use the furniture if instructions are not provided or if you cannot follow the instructions.

  • Verify a product's label, visit the manufacturer's website or ask the retailer to find out what safety features are available for the furniture you are considering.

  • Always use furniture for its intended purpose.

To report a tip-over related consumer complaint or incident, please contact your regional Health Canada Product Safety office toll free at 1-866-662-0666 or by e-mail at cps-spc@hc.gc.ca (please indicate the province or territory from which you are corresponding).

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Feb. 2, 2010

Recall: Fresh Boneless Beef Products

West Missouri Beef, LLC, a Rockville, Mo., establishment, is recalling approximately 14,000 pounds of fresh boneless 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 following products are subject to recall:

  • One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as "75 1-M," produced on October 26, 2009.

  • One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as "90 3-D," produced on November 25, 2009.

  • One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as "90 5-D," produced on November 27, 2009.

  • Combo bins containing approximately 2,000 pounds of fresh boneless beef identified as "90 2-P," "90 2-R" or "90 2-V," produced on December 8, 2009.

  • One combo bin containing approximately 2,000 pounds of fresh boneless beef identified as "90 3-E," produced on January 13, 2010.

Each container is marked with the establishment number "EST. 5821" inside the USDA mark of inspection. The fresh boneless beef products were distributed to wholesalers in the Chicago, Ill., area.

The problem was discovered by FSIS during a verification review performed at the establishment.

FSIS has received no reports of illnesses associated with consumption of these 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. 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.

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Feb. 2, 2010

Allergy Alert: Aahu Barah Brand Dry Apricot

Global Commodities Inc. of Hicksville, NY is recalling its 0.50 lbs. packages of Aahu Barah brand Dry Apricot food treats because they contain undeclared Sulfites. People who have allergies to Sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

The recalled Dry Apricots were distributed in New York State in some retail stores. The product comes in a 0.50 lbs., clear plastic package marked with Dry Apricot with an expiration date of 12/2013 stamped on the side.

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

The recall was initiated after routine sampling by NY State Agriculture & Markets inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 0.50 lbs. package of dried apricots which were not declared on the label. Subsequently, investigation indicated the problem was caused by a temporary breakdown in the company's production and packaging processes. Production of the product has been suspended until the company is certain that the problem has been corrected.

The consumption of 10 mg of sulfites per serving has been reported to illicit severe reactions in some asthmatics.

Consumers who have purchased 0.50 lbs. packages of Aahu Barah brand "Dry Apricot" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-516-396-0710 or 1-646-235-4154.

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Feb. 1, 2010

FDA Announces Safety Risk Associated with HIV Drug

The U.S. Food and Drug Administration announced on January 29 that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine).

Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.

During an 18-year period, 42 cases of non-cirrhotic portal hypertension were reported to the FDA's Adverse Event Reporting System for patients taking Videx/Videx EC. Four patients died from bleeding or liver failure after developing the condition.

Non-cirrhotic portal hypertension occurs when blood flow in the portal vein - a major vein in the liver - slows down and leads to severely enlarged veins in the esophagus. These enlarged veins, called esophageal varices, are thin and can break open, resulting in serious, and potentially fatal, bleeding.

The Videx and Videx EC product labels have been revised to help ensure that health care professionals and patients are aware of the risk and the signs and symptoms of non-cirrhotic portal hypertension.

The FDA evaluation concluded that the clinical benefits of Videx/Videx EC in certain patients with HIV continue to outweigh potential safety risks. Videx/Videx EC does not cure HIV infection, may not prevent development of HIV-related illnesses, and may not prevent the spread of HIV to other people.

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Feb. 1, 2010

List of Retail Stores for Sausage Recall

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 http://www.fsis.usda.gov/News_&_Events/ Recall_006_2010_Release/index.asp, 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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