FM/CFS/ME RESOURCES - Alerts, News & Product Recalls for June 2010

 

 
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 ALERTS, NEWS, PRODUCT RECALLS FOR THESE COUNTRIES:

  DATE  ALERTS, NEWS, RECALLS
June 30
June 28
June 26
June 25

June 24
June 23
June 22
June 18
June 17

June 16
June 15
June 11
June 8
June 7
June 3
June 2
June 1

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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.
Cancer
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Anxiety Attacks
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Fatigue
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Poor Exercise Tolerance
Rapid Heart Rate
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June 30, 2010

Texas Firm Recalls Cervelat Sausage Product

San Antonio Packing Company, a San Antonio, Texas, establishment, is recalling approximately 9,408 lbs. of Cervelat Summer Sausage because it may contain an undeclared allergen, milk, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. The recalled products do not have an ingredients statement. The product contains milk, a known potential allergen, which is not declared on the label. The following products are subject to recall:

  • 16 oz. packages of "APCO BRAND MEATS CERVELAT SUMMER SAUSAGE." Each package bears the establishment number "EST. 602" inside the USDA mark of inspection and a sell-by date up to Sept. 22, 2010.

These products were produced on various dates from April 14, 2010, through June 22, 2010, and were distributed to retail establishments in South Texas. When available, the retail distribution list(s) will be posted on FSIS' Web site.

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 Bobby Castaneda at (210) 224-5441.

Source:

* FSIS Recalls, Current Recalls and Alerts, June 30, 2010.

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June 30, 2010

Beef Stroganoff with Noodles Recalled

Oregon Freeze Dry, Inc. an Albany, Ore., establishment is recalling approximately 600 pounds of Beef Stroganoff with Noodles due to a mislabeling of individual pouches that were packed with Lasagna with Meat Sauce. The products subject to recall include:

  • 4.06-ounce pouches of "Mountain House Pro-Pak Beef Stroganoff with Noodles"

Each package bears the USDA mark of inspection "Est. 1394" as well as a "Best Use By" date of Feb 2017. Each package also has "EASY TO PREPARE" instructions on the back of the label. The products were produced on February 1, 2010, and were distributed nationwide on the wholesale and retail level as well as internet sales.

The problem was discovered by a consumer complaint to the establishment.

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 questions regarding the recall should be directed to the company's Assistant to the President, Becky Boyer at (541) 926-6001, Ext. 525. Consumers with questions about the recall should contact the company's Retail Sales Manager, Melanie Cornut at (541) 926-6001, Ext. 794.

Source:

* FSIS Recalls, Current Recalls and Alerts, June 30, 2010.

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June 30, 2010

Class 2 Drug Alert - Phenindione 25 mg Tablets

Goldshield Pharmaceuticals
Phenindione 25 mg Tablets
PL 10972/0038


Batch Number Expiry Date Pack Size First Distributed
68162 Feb 2012 1x28 03 Jun 2010

Goldshield Pharmaceuticals is recalling the above batch because some tablets within the batch are showing a dark orange/brown discolouration. The tablets are normally green. The cause of the discolouration is under investigation.

Since Goldshield Pharmaceuticals is the single source of this product, there may be supply issues. This is at present being addressed by the Company.

For medical information enquiries, please contact Goldshield Medical Information on 08700 703033, medicalinformation@goldshieldgroup.com.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics, general practitioners and community pharmacists.

Source:

* MHRA, United Kingdom, June 30, 2010.

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June 28, 2010

Class 4 Drug Alert - Acetylcysteine 200 mg/ml Injection

Aurum Pharmaceuticals Limited
Acetylcysteine 200mg/ml Injection
PL 12064/0026


Batch Number Expiry Date Pack Size First Distributed
80455 01 Oct 2010 10 x 10ml 12 Nov 2008
90114 30 Jun 2011 10 x 10ml 13 Aug 2009

Aurum Pharmaceuticals Limited has informed us that the two affected batches were packed in Martindale Pharma livery. In addition, the expiry date for batch 90114 has been corrected to 30 Jun 2011.

Aurum Pharmaceuticals Limited has informed us that black particles have been found in a very small number of ampoules from the above batches. Investigation has confirmed that the particles comprise carbonised material which forms if droplets of solution are present during sealing of the ampoules. Particles may be suspended in the solution, or may adhere to the inner wall of the ampoule neck in which case they may not be dislodged by shaking.

In order to avoid stock shortages, these batches are not being recalled. Provided this product is inspected as per normal parenteral practices, any affected ampoules should be detected and discarded.

For medical information enquiries please contact Aurum Pharmaceuticals Limited medical information on 01708 382791.

Source:

* MHRA, United Kingdom, June 28, 2010.

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June 28, 2010

Nationwide Recall of Magic Power Coffee Dietary Supplement

INZ DISTRIBUTORS INC./MAGIC POWER COFFEE INC. of Brooklyn, NY announced today that it is conducting a voluntary nationwide recall of the dietary supplement product sold under the name, Magic Power Coffee.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis of one lot of the product by the FDA found that the product contains undeclared hydroxythiohomosildenafil, similar in structure to Sildenafil, an FDA-approved drug used for the treatment of male Erectile Dysfunction (ED), making Magic Power Coffee an unapproved drug. The hydroxythiohomosildenafil drug ingredient is not listed on the product label.

Hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Magic Power Coffee is distributed nationwide on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing program. It is sold in a 2-serving box with UPC 718122686872 and a 12-serving carton containing six 2-serving boxes with UPC 718122686773. All production dates up until 05/08/2010 are being recalled.

To date, no illnesses have been reported to the company or the FDA in connection with this product.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Consumers should return any unused product to the place of purchase for full refund or contact INZ Distributors Inc./Magic Power Coffee Inc. at (718) 313-1579, Monday – Friday, 10 am to 6 pm EDT, for further instructions.

Source:

* FDA, Market Withdrawals, & Safety Alerts, June 28, 2010.

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June 26, 2010

Recall: BBQ Chicken Pizza Products That May Contain Foreign Materials

Great Kitchens, Inc., a Romeoville, Ill., establishment, is recalling approximately 109,800 pounds of BBQ chicken pizza products that may contain foreign materials, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. The following products are subject to recall:

  • 14-pound, 4-ounce cases of "MARKETSIDE, 16" BBQ CHICKEN PIZZA, 8-16" Pizzas," bearing case codes of "11016611," "11016621," "11016711," or "11016721."

  • 28.5-ounce "Marketside™, 16" BBQ RECIPE, Thin Crust, CHICKEN PIZZA."

Each box bears the establishment number "P-2539B" inside the USDA mark of inspection. The BBQ chicken pizza products were produced on June 15 and 16, 2010, and were shipped to distribution centers and retail stores nationwide.

The company discovered small pieces of plastic during production of 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 and media with questions about the recall should contact company President and CEO Gerald Coghlan at (815) 306-7171.

Source:

* U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS), June 26, 2010.

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June 25, 2010

P&G Voluntarily Recalls 4 Hour Decongestant Nasal Spray in the United States

The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling its 4-Hour Decongestant Nasal Spray. The product was distributed nationwide in the United States.

The company said it is taking this voluntary precautionary step after finding that the product formulation may not meet the expiration dates on the package. This recall is not a result of consumer complaints.

P&G is removing the product in question from store shelves. Consumers who have product with the UPC codes listed below and marked with an expiration date prior to June 2013 should simply discard the affected product. For further information on the product being recalled or to request a replacement coupon or refund call P&G toll-free at 877-340-8853 (Hours of operation: Monday - Friday, 9AM - 6PM US ET, Saturday, 10AM – 3PM US ET). The product name is:

VapoSpray 4 Hour Nasal Spray by Sinex with a UPC code of 3 23900 00082 7. Prior to June 2009, this product was also sold as Sinex Nasal Spray in both a spray (UPC Code 3 23900 00082 7) and Ultra Fine Mist package (UPC Code 3 23900 00085 8).

Anyone experiencing an adverse reaction or quality problem with this or any medication should consult a health care professional and notify the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

Source:

* FDA, Market Withdrawals, & Safety Alerts, June 25, 2010.

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June 25, 2010

Kellogg Recalls 4 cereals For Odor, Off Flavor

Working in consultation with the United States Food and Drug Administration (FDA), Kellogg Company is implementing a voluntary recall of certain breakfast cereals due to an uncharacteristic off-flavor and smell coming from the liner in the package.

Only products with the letters "KN" following the Better If Used Before Date are included in the recall. Products with a "KM" designation are NOT included in the recall. In addition, no products in Canada are affected.


Kellogg's Apple Jacks
  • UPC 3800039136 1: 17 ounce package with Better if Used Before Dates between APR 10 2011 and JUN 22 2011
  • UPC 3800039132 3: 8.7 ounce packages with Better if Used Before Dates between JUN 03 2011 and JUN 22 2011


Kellogg's Corn Pops
  • UPC 3800039109 5: 12.5 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  • UPC 3800039111 8: 17.2 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  • UPC 3800039116 3: 9.2 ounce packages with Better if Used Before Dates between APR 05 2011 and JUN 22 2011


Kellogg's Froot Loops
  • UPC 3800039118 7: 12.2 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  • UPC 3800039120 0: 17 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011
  • UPC 3800039125 5: 8.7 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011


Kellogg's Honey Smacks

  • UPC 3800039103 3: 15.3 ounce packages with Better if Used Before Dates between MAR 26 2011 and JUN 22 2011

While the potential for serious health problems is low, some consumers are sensitive to the uncharacteristic off-flavor and smell and should not eat the recalled products because of possible temporary symptoms, including nausea and diarrhea.

No other Kellogg's products are part of this recall. The recalled products were distributed nationwide.

"We apologize to our consumers and our customers and are working diligently to ensure that the affected products are rapidly removed from the marketplace," said David Mackay, president and chief executive officer, Kellogg Company.

Those with questions or who would like a replacement may contact the Kellogg Consumer Response Center at 888-801-4163 from 8 am to 8 pm Eastern time.

Source:

* Kellogg Company, June 25, 2010.

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June 25, 2010

Recall of product MONTEVERDI/LED CARLO/GAINING PRICE/DIA Mozzarellas

Product recalled by:
CIPF-Codipal

Mark:
MONTEVERDI/LED CARLO/GAINING PRICE/DIA

Product:
Mozzarellas

Reason for the recall:
Abnormal blue color related to the presence of the bacterium "pseudomonas"

Extra informations:
The bacterium "pseudomonas" can be dangerous for the elderly or if the immune system is weakened.

Consuming contact:
Tel.: 03 87 21 81 20

Source:

* rappelsproduits.fr, June 25, 2010.

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June 25, 2010

Recall: Fresh Spinach with Best Enjoyed By Dates of June 19 to June 27, 2010

Lancaster Foods, LLC is voluntarily recalling fresh Spinach with the Best Enjoyed By dates of 19 JUN 10 through 27 JUN 10 sold under the brand names Krisp-Pak, Lancaster Fresh, Giant, and America's Choice because they could be contaminated with Listeria monocytogenes. The recall extends only to products with this Use-by Date or Product Code and sold in the following states: New Jersey, Delaware, Pennsylvania, Maryland, North Carolina, and Virginia. No other Lancaster Foods, LLC products are included in the recall.

The recall notification is being issued out of an abundance of caution based on a random sample test conducted by the North Carolina Department of Agriculture Food & Drug Protection Division (NCAGR) on fresh Spinach with the Best Enjoyed By dates of 23 JUN 10 sold under the brand name Krisp-Pak that was confirmed positive for Listeria monocytogenes in NCAGR labs. No illnesses have been associated with this possible contamination.

Although healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria M. infection can cause serious and sometimes fatal infections in young children, frail, or elderly people, and others with weakened immune systems. It can also cause miscarriages and stillbirths among pregnant women. Consumers with any of these symptoms should consult their health care provider.

Because it is still possible that the spinach with the Best Enjoyed By dates of 19 JUN 10 through 27 JUN 10 sold under the brand names Krisp-Pak, Lancaster Fresh, Giant or America's Coice could be on store shelves, this recall extends to retailers as well as consumers. Lancaster Foods, LLC believes that it is important to alert consumers who might still possess one of the potentially affected expired packages of spinach to immediately dispose of it.

Spinach included in the recall notification includes the items listed in the table below with Best Enjoyed By dates of 19 JUN 10 through 27 JUN 10.


Instructions for Consumers:

Check your refrigerator for packaged fresh Spinach with the Best Enjoyed By dates of 19 JUN 10 through 27 JUN 10 sold under the brand name Krisp-Pak, Lancaster Fresh, Giant, or America's Choice. The Use-by Date is found on the front of the package in the upper right hand corner.

Consumers who may have potentially affected product are asked to empty the contents of the package into your garbage, save the package, and contact a Lancaster Foods, LLC consumer representative toll-free at (800) 247-8125 between the hours of 8:00 am to 5:00 pm.

Complete Listing of Recalled Lancaster Foods, LLC spinach packed under the Krisp-Pac, Lancaster Fresh, Giant, and America's Choice brands, Use-by Dates and Product Codes.


Bag UPC Code Product Description Oz
33383 65201 Krisp-Pak Hydro-Cooled Fresh Spinach, Best Enjoyed by 19 JUN 10 thru 27 Jun 10 10 oz
13055 01145 Lancaster Fresh, Triple Washed, All Natural, Curly Leaf Spinach, Best Enjoyed by 19 JUN 10 thru 27 JUN 10 8, 10, and 12 oz
88267 09813 Giant, Fresh Spinach, Best Enjoyed by 19 JUN 10 thru 27 JUN 10 10 oz
54807 76060 America's Choice, Spinach, Cold Water Washed, Best Enjoyed by 19 Jun 10 thru 27 Jun 10 oz

Source:

* FDA, Market Withdrawals, & Safety Alerts, June 25, 2010.

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June 25, 2010

Gluten Free Molasses Licorice Recalled

Name of Product:
Orgran Gluten Free Molasses Licorice 200g

Package Description & Size::
200g plastic package

Identification:
Best Before: 31 October 2011

Distribution:
Selected supermarkets and health stores throughout New Zealand. Made in and supplied from Australia to NZ and other countries.

Reason for Recall:
Undeclared Allergen - Gluten

Comments:
Orgran Gluten Free Molasses Licorice (Orgran Natural Foods) 200g displaying Best Before 31 October 11 should not be consumed due to the presence of undeclared allergen gluten.

There have been no reports of illness, however any person concerned about their health should seek medical advice.

Customers should return this product to their retailer for a full refund or phone Crombie and Price Ltd on 3 434 8311 with any queries.

Crombie & Price Ltd
5 Torridge Street, Oamaru 9400
Phone: 03 434 8311

Source:

* New Zealand Food Safety Authority, Recalled Food Products, June 25, 2010.

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June 24, 2010

Illinois Firm Recalls Imported Beef Products Due to Potential Animal Drug Contaminant

Sampco, Inc., a Chicago, Ill., establishment is recalling approximately 61,000 pounds of cooked canned and frozen beef products that may contain the animal drug Ivermectin, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.

On May 14, 2010, FSIS issued Recall News Release FSIS-RC-033-2010, a Class II recall with low health risk, which also announced the agency was taking a number of actions regarding lots of cooked beef from Brazil after the agency found that they may contain the animal drug Ivermectin. Ivermectin is a broad-spectrum antiparasitic and is used as a de-worming agent in live animals. FSIS routine point of entry testing had discovered samples of cooked beef product from Brazil that were produced on January 20, 2010, that exceeded the tolerance level established by the U.S. Department of Health and Human Services' Food and Drug Administration in beef muscle. While that product was not permitted entry into the U.S., FSIS subsequently determined that associated product may have entered the country separately, resulting in today's recall.

Based on Brazil's voluntary suspension of export for cooked beef products, FSIS has broadened its ongoing investigation. FSIS may take further regulatory action as it continues its investigation.

FSIS is also alerting consumers although the agency has received no reports of illness or adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a physician. Consumers who have purchased any of these products should return them to their point of purchase. The following products are subject to recall

  • 12 oz. cans of "Deltina CORNED BEEF WITH JUICES" with the production code "100120" inkjetted on the top of the can. These products were sent to a distribution center in Florida for retail sales.

  • 12 oz. cans of "Hormel CORNED BEEF WITH NATURAL JUICES" with the production code "100120" inkjetted on the top of the can. These products were sent to distribution centers in Guam for retail sales.

  • 35 lb. boxes of frozen "SEASONED COOKED BEEF." These products were distributed to federal establishments for further processing.

  • 35 lb. boxes of "Sampco Brand FROZEN COOKED BEEF, Salt Added." These products were distributed to federal establishments for further processing.

Each product package bears "BRASIL 337 S.I.F," as well as "Product of Brazil" or "Packed under Brazilian Government Inspection." The products subject to recall were produced in Brazil on January 20, 2010.

Media and consumer questions regarding the recall should contact the company hotline at (800) 685-6328.

Source:

* U.S. Department of Agriculture's Food Safety and Inspection Service, June 24, 2010.

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June 24, 2010

EH Booth and Co. Ltd withdraws Chateau Ducla French AC Bordeaux Superior

Product:
Chateau Ducla French AC Bordeaux Superior

Product Identification:
Product: Chateau Ducla French AC Bordeaux Superior 2005 and 2006 vintage.
Size: 75cl


Batch Numbers:
  • 2005: 08HO8 – L5184050-44990
  • 2006: 09HO9 – L5184060-50498

Risk:
The above product contains sulphites that are not declared on the label, making this product a potential risk to consumers who are sensitive to sulphites.

Action taken by the company:
EH Booth and Co Ltd has withdrawn the affected batch from sale. In addition, the company has contacted the relevant allergy support organisations, which will inform their at risk members of the withdrawal. Notices will be displayed in all stores to alert consumers to the reasons for the withdrawal and the actions they can take if they have purchased the product. A copy of the notice can be viewed via the link below. No other EH Booth and Co Ltd products are known to be affected.

Advice to Consumers:
Customers with a sensitivity to sulphites are advised not to drink this product.

Source:

* Food Standards Agency, United Kingdom, June 24, 2010.

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June 24, 2010

Class 4 Drug Alert: Aurum Pharmaceuticals Limited - Acetylcysteine 200mg/ml Injection

Aurum Pharmaceuticals Limited
Acetylcysteine 200mg/ml Injection
PL 12064/0026

Batch Numbers:

  • 80455
  • 90114

Expiry Dates:

  • 1 October 2010
  • 30 June 2011

Pack Sizes:

  • 10 x 10ml
  • 10 x 10ml

First Distributed:

  • 12 November 2008
  • 13 August 2009

Aurum Pharmaceuticals Limited has informed us that black particles have been found in a very small number of ampoules from the above batches. Investigation has confirmed that the particles comprise carbonised material which forms if droplets of solution are present during sealing of the ampoules. Particles may be suspended in the solution, or may adhere to the inner wall of the ampoule neck in which case they may not be dislodged by shaking.

In order to avoid stock shortages, these batches are not being recalled. Provided this product is inspected as per normal parenteral practices, any affected ampoules should be detected and discarded.

For medical information enquiries please contact Aurum Pharmaceuticals Limited medical information on 01708 382791.

Source:

* MHRA, Safety Warnings, Drug Alerts, United Kingdom, June 24, 2010.

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June 23, 2010

St. John Ambulance Australia Inc. Survival Saline Solution Recalled

Product Description:
Survival Saline solution 15 ml

Identifying Features:
Supplied in the following St John First Aid Kits purchased during September 2009 - December 2009
Leisure Small - Batch SJ0902
Leisure Medium - Batch SJ0903
Leisure Large Batch - SJ0904
Lot 20090715, ARTG no. 155522

Hazards:
Illness or mistreatment

Defects:
This batch of Survival Saline solution has been found to be contaminated and may cause infection.

Product Sold:

  • National

Dates Available for Sale:
September 2009 - December 2009

Supplier:
St John Ambulance Australia Inc.

What Should Consumers Do?
If you have any vials of Survival 15ml Saline Solution (Batch 20090715) DO NOT USE IT. Please destroy the vials and you will be sent replacements. Please call Customer Service on: 1300 598 829 or (02) 8788 1362

Source:

* Product Safety Recalls, Australia, June 23, 2010.

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June 23, 2010

South Gate Meat Co. Recall: Ground Beef Products Due To Possible E. coli Contamination

South Gate Meat Co., a South Gate, Calif., establishment, is recalling approximately 35,000 pounds of ground 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 products subject to recall include:

  • 20, 30 and 40 pound bulk packages of "SOUTH GATE MEAT CO. GROUND BEEF."

  • 30, 40, and 50 pound bulk packages of "SOUTH GATE MEAT CO. COARSE GROUND BEEF."

  • 10 and 20 pound packages of "SOUTH GATE MEAT CO. GROUND BEEF PATTIES."

Each package bears establishment number "EST. 6217" inside the USDA mark of inspection. These ground beef products were produced between the dates of June 7, 2010, through June 21, 2010, and were shipped to restaurants in the Los Angeles and Orange County, Calif. area.

The problem was discovered through FSIS microbiological sampling which confirmed a positive result for E. coli O157:H7. FSIS and the company have 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.

Media and consumer questions regarding the recall should be directed to the company's owner, John Dritsas and the company's Vice President, Angelo Dritsas respectively at (323) 564-1701.

Source:

* U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS), June 23, 2010.

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June 22, 2010

Recall: Ground Beef Products Due To Possible E. coli Contamination

Crown I Enterprises, Inc., a Bay Shore, N.Y., establishment, is recalling approximately 3,700 pounds of ground 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 products subject to recall include:

  • 24, 8-ounce burgers in 12-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED, BURGER FRESH, WB HOME STYLE 8 OZ."

  • 32, 6-ounce burgers in 12-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED, BURGER FRESH 6 OZ."

  • 48, 4-ounce burgers in 12-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED, BURGER FRESH, 4 OZ."

  • 10-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED, BEEF GROUND/EXTRA LEAN."

  • 10- and 20-pound boxes of "W.B. STOCKYARD, KEEP REFRIGERATED, BEEF GROUND 80/20."

Each package bears establishment number "EST. 20889" inside the USDA mark of inspection as well the Julian dates of "10164" and "10166." These ground beef products were produced on June 11, 2010, and June 15, 2010, and were shipped to food service institutions in Conn., N.J., and N.Y.

The problem was discovered through FSIS microbiological sampling which confirmed a positive result for E. coli O157:H7. FSIS and the company have 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.

Media and consumer questions regarding the recall should be directed to the company's Vice President of Operations, Kevin Peterson, at (631) 289-8401, ext. 2222.

Source:

* U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS), June 22, 2010.

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June 18, 2010

Orgran Gluten Free Molasses Licorice Recalled

Product Description:
Package Description: Plastic pouch (resealable)
Package Size: 200g
Country of Origin: Australia

Identifying Features:
Date Marking: Best before: 31 Oct 11

Hazards:
Illness

Defects:
Labelling – Undeclared allergen (gluten)

Product Sold:

  • NSW
  • QLD
  • SA
  • TAS
  • VIC
  • WA

Traders who Sold Product:
The products have been on the market place for nine weeks, (Distributed from the warehouse 15th April 2010). This product is distributed to small businesses, health food stores and specialty stores.

Supplier:
Roma Food Products

What Should Consumers Do?
Return to place of purchase for full refund

Source:

* Product Safety Recalls, Australia, June 18, 2010.

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June 18, 2010

Solomon Kosher Butcher Pty Ltd Premium Beef Mince Recalled

Product Description:
Premium beef mince (diet beef mince) purchased on 16th June 2010 or 17th June, 2010.
All weights, no printed package – sold loose and for immediate use (customers told to consume immediately or freeze within 24h of purchase).
Country of Origin: Australia

Hazards:
Illness

Defects:
Foreign matter – rubber washing-up glove

Product Sold:
VIC

Traders who Sold Product:
Café D'Lish on Bambra, Daneli's Deli, Eshel Take Away, Kleins Kosher Gourmet, Myflame Restaurant and Sue Kluwgant.

Supplier:
Solomon Kosher Butcher Pty Ltd

What Should Consumers Do?
Return the product to the point of purchase with proof of purchase for immediate full cash refund.

Source:

* Product Safety Recalls, Australia, June 18, 2010.

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June 18, 2010

Iowa Firm Recalls Frozen Chicken Products Due To Possible Salmonella Contamination

ConAgra Foods Packaged Foods, LLC, a Council Bluffs, Iowa establishment is recalling Marie Callender's brand Cheesy Chicken and Rice frozen meals, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The company is recalling all Marie Callender's brand Cheesy Chicken and Rice frozen meals in commerce, regardless of production date. These products are being recalled after the company was informed by the U.S. Centers for Disease Control and Prevention (CDC) of an investigation involving 29 people in 14 states who have been diagnosed with salmonellosis linked to Salmonella serotype Chester. Eight of the case-patients specifically reported eating this product in April and May, 2010, prior to illness onset; the last reported illness was reported on May 22.

  • 13-ounce packages of "Marie Callender's Cheesy Chicken & Rice White Meat Chicken and Broccoli over Rice Topped with Rich Cheddar Sauce."

Each package bears a label with establishment number "P-45" 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. When available, the retail distribution list(s) will be posted on FSIS' Web site.

FSIS became aware of the problem during the course of an ongoing investigation of a multi-state outbreak of Salmonella serotype Chester illnesses. CDC, the Food and Drug Administration (FDA), FSIS, and state health and agriculture departments are cooperating in this ongoing investigation. The investigation is ongoing, and has not yet definitively identified a food vehicle(s). Further information will be released to the public as it becomes available.

Consumers with questions about the recall should contact ConAgra Foods at 1-866-484-9610. Media questions regarding the recall should be directed to Teresa Paulsen, Vice President of Communications and External Relations at (402) 240-5210.

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.

Source:

* FSIS, News Releases, June 18, 2010.

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June 18, 2010

Texas Firm Recalls Three Varieties of Spaghettios With Meatballs

Campbell Soup Supply Company, LLC, a Paris, Texas, establishment is recalling approximately 15,000,000 pounds of "SpaghettiOs with Meatballs" canned products due to possible under-processing, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. The following products are subject to recall:

  • 14.75-ounce cans of "SpaghettiOs" with Meatballs, bearing the identifying product code "U5" on the bottom of the can.

  • 14.75-ounce cans of "SpaghettiOs" A to Z with Meatballs, bearing the identifying product code "4N" on the bottom of the can.

  • 14.75-ounce cans of "SpaghettiOs" Fun Shapes with Meatballs (Cars), bearing the identifying product code "KS" on the bottom of the can.

The products subject to recall bear the establishment number "EST 4K," as well as a "Use By" date between June 2010 and December 2011 ink-jetted on the bottom of each can. These products were manufactured between December 2008 and June 2010 and distributed to retail establishments nationwide.

RETAIL DISTRIBUTION LIST.

The problem was discovered through a routine warehouse inspection by the company and its subsequent investigation. FSIS has received no reports of illnesses from consumption of 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.

Consumer questions regarding the recall should be directed to Campbell's Hotline at (866) 495-3774; media inquiries should be directed to the company's Director of Corporate Communications, Anthony Sanzio at (856) 968-4390.

Source:

* FSIS, News Releases, June 18, 2010.

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June 17, 2010

Recall: Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are:

  • Four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.

  • One product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico

Product Name Product Form Lot Number NDC Number UPC Code
BENADRYL Allergy ULTRATAB Tablets 100 count Ultratab Tablet AJA008, ADA194, ABA022, ABA264 50580-226-10 312547170338
EXTRA STRENGTH Tylenol Rapid Release Gels 50 count Rapid Release Gelcap ASA202 50580-488-50 300450488503

This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.

BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.

The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com1 or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).

Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website.

The product lot numbers for the recalled products can be found on the side of the bottle label.

Source:

* FDA, Market Withdrawals, & Safety Alerts, June 17, 2010.

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June 17, 2010

Recall: All Jacobs Well Egg Farm Eggs

Product Information:
Cardboard egg cartons and catering packs
Country of Origin: Australia

Identifying Features:
APN/EAN/TUN NUMBER:
Medium 500g 9332022005000
Large 600g 9332022006007
Extra Large 700g 9332022007004
Jumbo 800g 9332022008001

Hazard:
Illness

Defects:
Microbial - Salmonella

Where Product Was Sold:
QLD

Supplier:
Jacobs Well Egg Farm

Traders Who Sold Product:
The affected product has been distributed to Rocklea Markets, IGA stores, Foodlink and corner stores in South East Queensland and has been on the market for 3 to 4 weeks.

Advice to Consumers:
Return to place of purchase for full refund.

Source:

* Product Safety Recalls, Australia, June 17, 2010.

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June 17, 2010

Recall: Asda Indian Tikka Masala & Jalfrezi Meal for 2

Product Information:
Asda Indian Tikka Masala & Jalfrezi Meal for 2
Pack size: 1.37kg
Use by: 20 June 2010

Risk:
Due to a packaging error, the above product has been packed with a Korma meal instead of the Tikka Masala & Jalfrezi meal and therefore contains cashew nuts. The presence of undeclared cashew nuts poses a public health risk to those allergic to nuts. The allergen advice box does include a 'may contain traces of nut' warning but does not declare the presence of nuts.

Action By Company:
The company has withdrawn the affected product and has contacted the relevant allergy support organisations, which will inform their at-risk members of the withdrawal. Notices are being displayed in all stores to alert consumers to the reasons for the withdrawal and the actions they can take if they have purchased the product. A copy of the point-of-sale notice issued by Asda can be viewed via the link below. No other Asda products are known to be affected.

Advice to Consumers:
Customers with an allergy to nuts are advised not to eat this product.

Source:

* Food Standards Agency, United Kingdom, June 17, 2010.

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June 16, 2010

Recall: Hovis Hearty Oats Loaf Due to Potential Glass Contamination

Product Information:
Hovis Hearty Oats Loaf, 800g
All loaves with a best before date, up to and including 20 June 2010.

Risk:
A small number of the above product potentially contain small pieces of glass.

Action By Company:
The company has recalled the affected product from consumers. The company has placed a Press Recall Statement in several national publications on 16 June, explaining to customers the reason for recall and the actions they can take if they have bought the affected product. No other Hovis products are known to be affected.

Advice to Consumers:
If you have purchased a Hovis Hearty Oats Loaf with a best before date code of the 20 June or earlier, please do not consume the product. For refund information please refer to the company's recall notice.

Source:

* Food Standards Agency, United Kingdom, June 16, 2010.

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June 15, 2010

Recall: Cooked, Frozen Claw Island Brand, Craig's All Natural Brand and Inland Ocean Brand Lobster Claw and Knuckle Meat Because of Possible Health Risk

Portland Shellfish Company, Inc. is voluntarily recalling the following brands of cooked, ready to eat fresh or frozen lobster meat: Portland Shellfish Co. Inc brand, Claw island, Craig's All Natural, and Inland Ocean cooked, fresh or frozen lobster claw and knuckle meat as recent tests show the product 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 infection can cause miscarriages and stillbirths among pregnant women. The recalled products were distributed nationwide in wholesale and retail stores.

  • LOBSTER CLAW & KNUCKLE MEAT, CS 6 x 2 LB, packed under the Claw Island, Craig's All Natural or Inland Ocean brand, production lot numbers 13210, 13310, and 13410, shipped between 05/14/2010 and 05/26/2010.

  • LOBSTER KNUCKLE MEAT, CS 6 x 2 LB, packed under the Inland Ocean brand, production lot numbers 13210, shipped on 05/13/2010.

  • LOBSTER CLAW & KNUCKLE MEAT, CS 18 x 15 oz, packed under the Claw Island brand, production lot numbers 13210 and 13410, shipped between 05/25/2010 and 06/08/2010.

  • LOBSTER CLAW & KNUCKLE MEAT, CS 20 x 8 oz, packed under the Craig's All Natural brand, production lot numbers 13210, shipped on 05/14/2010.

  • LOBSTER KNUCKLE MEAT, 1 LB bag, fresh, packed under Portland shellfish brand, production lot number 13310, shipped on 05/12/2010.

  • LOBSTER CLAW & KNUCKLE MEAT, 4 oz bag, fresh, packed under Portland shellfish brand, production lot number 13310, shipped on 05/13/2010.

  • LOBSTER CLAW & KNUCKLE MEAT, 1 LB bag, fresh, packed under Portland shellfish brand, production lot number 13210 and 13310, shipped on 05/12/2010 and 05/13/2010.

  • LOBSTER CLAW & KNUCKLE MEAT, 2 LB bag, fresh, packed under Portland shellfish brand, production lot number 13210 and 13310, shipped on 05/12/2010 05/13/2010, 05/14/2010.

  • LOBSTER CLAW & KNUCKLE MEAT, 5 LB bag, fresh, packed under Portland shellfish brand, production lot number 13210, shipped on 05/12/2010.

Consumers who have purchased these products are urged not to consume it and to return the product to the place of purchase for a full refund. Consumers with questions may contact the company at 207-699-5505, Monday through Friday between 8:00 a.m to 5:00 p.m No related foodborne illnesses have been reported to date.

Source:

* FDA, Market Withdrawals, & Safety Alerts, June 15, 2010.

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June 15, 2010

Undeclared Sulfites in Strawberry Farms Sun Dried Tomatoes

Sirob Imports, Inc. of Lindenhurst, NY, is recalling 16 oz vacuum packed bags of Strawberry Farm Sun Dried Tomatoes because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life threatening allergic reactions if they consume this product.

The product comes in 16 oz, clear plastic vacuum packed bags. The recalled Strawberry Farm Sun Dried Tomatoes were distributed in Queens, NY to a retail store.

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 16 oz vacuum packed bags Strawberry Farm Sun Dried Tomatoes which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfites sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of the Strawberry Farms Sun Dried Tomatoes revealed they contained 197 milligrams per 4 oz serving.

No illnesses or allergic reactions involving this product have been reported to date. Consumers who have purchased 16 oz vacuum packed bags Strawberry Farm Sun Dried Tomatoes are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 631-957-8888.

Source:

* FDA, Market Withdrawals, & Safety Alerts, June 15, 2010.

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June 11, 2010

Morrisons Chicken Chow Mein Recalled

Product Information:
Morrisons Chicken Chow Mein, 400g
Use by: 12 June 2010
Description: Black filmed tray with cardboard sleeve

Risk:
Due to a packaging error, a very small number of packs actually contain Morrisons Chicken Fried Rice. As a result, the presence of egg and milk are not declared on the label. Therefore, this makes the product a potential health risk for people who are allergic to egg or allergic/intolerant to milk or milk constituents.

Action By Company:
The company has recalled the affected product and has contacted the relevant allergy support organisations, which will inform their at-risk members of the recall. Notices are being displayed in all stores to alert consumers to the reasons for the recall and the actions they can take if they have purchased the products. A copy of the point-of-sale notice issued by Wm Morrison Supermarkets is attached to this Allergy Alert. No other Wm Morrison Supermarkets products are known to be affected.

Advice to Consumers:
Customers with an allergy to egg and/or an allergy/intolerance to milk or milk constituents are advised not to eat this product.

Source:

* Food Standards Agency, United Kingdom, June 11, 2010.

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June 11, 2010

Recall: Madelaine Gummy Baby Crocodiles Day Old Chicks and Gummy Coral Fish

Product Information:
Brand Name: Madelaine Gummy Baby Crocodiles, Madelaine Gummy Day Old Chicks and Madelaine Gummy Coral Fish
Package Description: Plastic jar
Package Size: 140g
Country of Origin: Vietnam
Best Before: 20/04/12, Batch Number 20/04/10J12

Hazards:
Illness

Defects:
Foreign matter - metal pieces

Product Sold:
National

Traders Who sold Product:
Woolworths/Safeway

Supplier:
Madelaine Confectionery Pty Ltd

Advice to Consumers:
Return to place of purchase for a full refund.

Source:

* Product Safety Recalls, Australia, June 11, 2010.

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June 8, 2010

Undeclared sulphur dioxide in Tree of Life Dried Apricots

Product:
Tree of Life Dried Apricots

Risk:
The above product contains sulphur dioxide that is not declared on the label, making this product a potential risk to consumers who are sensitive to sulphites.

Product Identification:
Product: Tree of Life Dried Apricots
Size: 1kg packs, 12.5kg, 125kg, 250kg, 500kg
Batch number/date codes: All product to be removed from sale

Action taken by the company:
The company has contacted all of its customers, advising them of the need to remove the product from sale until it is over-labelled with the correct ingredients information. The company has notified the relevant allergy support organisations who will contact there at-risk members. No other Tree of Life Ltd brand products are known to be affected.

Advice to Consumers:
Customers with a sensitivity to sulphites are advised not to eat this product.

Source:

* Food Standards Agency, United Kingdom, June 8, 2010.

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June 8, 2010

Co-operative Recalls 4 Types of Wine

The Co-operative has recalled some 75cl bottles of wine from customers because the products might contain small pieces of glass. The Agency has issued a Product Recall Information Notice.

Details of the four types of wine being recalled and the affected lot codes can be found below. Each lot code, which appears on the label on the back of the bottle, begins with the letter 'L' and is followed by five numbers.

  • Co-operative Californian The Pink Chill Zinfandel Rose, 75cl
  • L10120, L10126, L10127, L10128, L10130, L10131, L10132 and L10144

  • Co-operative Californian The Fab Cab Ruby Cabernet Shiraz, 75cl
  • L10132 and L10133

  • Co-operative Californian The Big Chill Colombard Chardonnay, 75cl
  • L10119, L10120, L10134, L10137 and L10138

  • Silver Creek Sauvignon Blanc, 75cl
  • L10133 and L10134

Product recall notices have been displayed in stores that sell the product, explaining why the products have been recalled and how customers can get a full refund. If you have bought any of the affected wine, you can contact The Co-operative by calling freephone 0800 0686 727 for a full refund. No other Co-operative products are known to be affected.

Source:

* Food Standards Agency, United Kingdom, June 8, 2010.

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June 7, 2010

Eastern Fish Recalls Hannaford and Bloom Private Brand Frozen Raw Extra Jumbo Shrimp

Teaneck, N.J. Eastern Fish is alerting consumers that Hannaford Supermarkets and Bloom brands of frozen raw extra jumbo (16/20) shrimp in 16 oz packages, as well as these brands of shrimp from the full-service seafood cases, labeled as product of Mexico, sold May 4 through June 4 at Hannaford Supermarkets and sold April 8 through June 4 at Bloom grocery stores, are subject to a voluntary recall because the products may contain undeclared sulfites. People who have an allergy or sensitivity to sulfites risk an allergic reaction if they consume these products.

To date, the company has received no reports of adverse reaction associated with these products. Customers are asked to return any Hannaford or Bloom brands of frozen 16/20 shrimp products to their store for a full refund if the Hannaford or Bloom frozen extra jumbo shrimp product of Mexico were purchased from Hannaford Supermarkets or Bloom grocery stores during the specified timeframes.

These products were distributed to Hannaford stores and to independent stores serviced by Hannaford in:

  • New York
  • Massachusetts
  • New Hampshire
  • Vermont
  • Maine

and to Bloom stores in:

  • North Carolina
  • South Carolina
  • Virginia
  • Maryland

The recall was initiated after Bloom was notified by the North Carolina Department of Agriculture that test results from routine product sampling indicated the presence of sulfites in the shrimp. Eastern Fish is cooperating fully with the FDA.

    Product Description
  • Hannaford Raw Shrimp Extra Jumbo E-Z Peel Shrimp, 16-20 shrimp per pound, (UPC code: 04126813037) (product of Mexico). With the following datescodes:PGC33509,PGC33609,PGC33709,PGC33809,PGC34109

  • PGC34209

  • Bloom Private Brand Frozen Raw Extra Jumbo Shrimp (UPC code: 72543990374) (product of Mexico).with the following dates codes:PGC33109,PGC33409,PGC33509

  • The products come in 16 oz. bags.

Consumers who have purchased these products during the specified timeframes may return them to any Hannaford or Bloom store for a full refund.

Source:

* FDA, Market Withdrawals, & Safety Alerts, June 7, 2010.

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June 7, 2010

Recall of All Lots of Ondansetron in 5% Dextrose Injection, 32 mg/50 mL

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of all lots of:

  • Ondansetron injection in 5% dextrose 32mg / 50 mL (NDC number 25021-776-50)

Manufactured by Claris Lifesciences and distributed by Sagent. The lot numbers being recalled are:

  • A090309
  • A090310
  • A090311
  • A090312

Which were distributed to hospitals, wholesalers and distributors nationwide from August 2009 through May 2010. Ondansetron injection is an intravenous product used to treat nausea and vomiting associated with chemotherapy or surgery and is supplied in a single dose plastic container.

Sagent has initiated this voluntary recall of ondansetron to the user level in conjunction with Claris Lifesciences' recall due to the discovery of foreign material and non-sterility in one lot of ondansetron injection. Non-sterility of an antiemetic administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.SagentPharma.com1. Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about ondansetron injection may contact Sagent Medical Affairs (866-625-1618 option 3).

Source:

* FDA, Market Withdrawals, & Safety Alerts, June 7, 2010.

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June 3, 2010

Parents Reminded: 'Honey is not suitable for babies'

The Food Standards Agency is reminding parents not to feed honey to babies who are under a year old. This follows a case of the rare but serious illness, infant botulism.

There have only been 11 confirmed cases of infant botulism in the past 30 years, but three of these have occurred in the past year and all have had possible links to honey. The most recent case involved a 15-week-old baby.

Honey is safe for children over the age of one, but a younger baby's gut is not sufficiently developed to be able to fight off the botulism bacteria. This is why parents are advised not to give babies honey until they are one year old.

Sam Montel, nutritionist at the Food Standards Agency, said: 'For around the first six months babies only need breast milk or infant formula and although it might be tempting to give honey to your baby to ease coughs, infant botulism is a very serious illness and it simply isn't worth the risk.

'Once introduced to solid foods, it's always best to avoid sweetening your baby's food or giving them sugary snacks and drinks, this will help stop them developing a sweet tooth and tooth decay.'

Source:

* Food Standards Agency, United Kingdom, June 3, 2010.

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June 3, 2010

Update on Products Free of Colours Associated with Hyperactivity

The Agency has updated its list of product ranges that do not contain the six food colours associated with possible hyperactivity in young children. Another manufacturer producing product lines free of the colours has been added to the list: Candyking Ltd's Candyking products.

The list includes companies whose product ranges have never contained the six colours and companies whose product ranges that have been reformulated to remove the colours. The colours, identified by a Southampton University study financed by the Food Standards Agency, are:

  • sunset yellow FCF (E110)
  • quinoline yellow (E104)
  • carmoisine (E122)
  • allura red (E129)
  • tartrazine (E102)
  • ponceau 4R (E124)

The Agency is publicising the product ranges to encourage the food industry to participate in the voluntary ban. The voluntary ban was agreed by Ministers in November 2008.

Consumers who are particularly concerned about the presence of the colours should continue to check labels, especially in the case of products with a long shelf-life, where the availability of reformulated products may vary.

Any food manufacturer, retailer or caterer wishing to notify the Agency that their brands or products are free of these colours, should email the details to Benedict Duncan, at benedict.duncan@foodstandards.gsi.gov.uk.

Source:

* Food Standards Agency, United Kingdom, June 3, 2010.

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June 3, 2010

OM Fusion Removed from the Canadian Market

The Issue:
Following a February 2010 Advisory concerning unauthorized products sold under the OM Fusion Distributors LLC label, additional unauthorized products with the OM Fusion label have been removed from the Canadian market by Health Canada.

The labels for Valocormid and Voltaren indicate the products contain ingredients that legally require the products to be sold by prescription because they are used to treat serious diseases or may have side effects that require monitoring by a health care practitioner. Additional unauthorized OM Fusion health products were sold in Canada with packaging in Russian, Ukrainian or Kazakh languages only. As a result, important information about the proper use and potential side effects of these products may not be understood by consumers.

What Consumers Should Do:
Consult your healthcare practitioner if you have used any of these products and are concerned about your health.

Read the labelling of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health 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.

Background:
The ingredients listed on the label of the Valocormid and Voltaren products can cause serious health problems. If you have taken products containing these ingredients without the supervision of a health care practitioner or without a prescription you may face additional risks. You may be misdiagnosed, the treatment might not be appropriate to treat your illness and you may miss the opportunity to obtain appropriate medical treatment. You may also put yourself at risk for drug interactions, or harmful side effects.

For More Information:
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709. Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

Source:

* Health Canada, Advisories, Warnings & Recalls, June 3, 2010.

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June 2, 2010

Ciprofloxacin, Metronidazole and Ondansetron Recalled

Claris Lifesciences today announces the voluntary nationwide recall of all lots of:

  • Ciprofloxacin Inj. USP 200 mg / 100 mL (NDC 36000-008-24)
  • Ciprofloxacin Inj. USP 400 mg / 200 mL (NDC 36000-009-24)
  • Metronidazole Inj. USP 500 mg/100 ml (NDC 36000-001-24)
  • Ondansetron in 5% Dextrose Inj. 32 mg / 50 mL (36000-014-06)

Manufactured and distributed by Claris Lifesciences. All lots are being recalled, which were distributed to hospitals, wholesalers and distributors nationwide.

Claris has initiated this voluntary recall of the product listed above to the user level as a precautionary measure against possible contamination due to packaging integrity of the product. Claris is initiating a voluntary recall of the products listed above because it has received reports of floating matter which may pose risk if administered to patients. Healthcare professionals should NOT use these products, and should immediately remove them from their pharmacy inventories. This recall is made with the full knowledge of the Food and Drug Administration. Claris is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation.

Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at http://www.clarislifesciences.com/Claris_USA/index.asp. Any questions about returning unused product should be directed to the customer call center at +1 (877) 725- 2747, M-F 8am-7pm CST. Healthcare workers who have medical questions about the products may contact the same number and ask for Medical affairs.

Source:

* FDA, Market Withdrawals, & Safety Alerts, June 2, 2010.

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June 2, 2010

Class 2 Drug Alert: Gabapentin 100mg Capsules

Product Description:
Ranbaxy (UK) Limited
Gabapentin 100mg Capsules
PL 14894/0530

Batch #:
2037862

Expiry Date:
May 2011

First Distributed:
10 Sep 2009

Comments:
Ranbaxy (UK) Limited is recalling all unused stock of the above batch because the patient information leaflet (PIL) has not been updated to include safety warnings initiated by the European Medicines Agency. The missing text should be positioned under the heading 'Take special care with' and states the following:

'A small number of people being treated with anti-epileptics such as Gabapentin have had thoughts of harming and killing themselves. If at any time you have these thoughts, immediately contact your doctor'

For any stock enquiries please contact Ranbaxy (UK) Limited on 0208 742 5299. For medical information enquiries, please contact Ranbaxy (UK) limited on 0208 742 5292.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to forward this to relevant clinics, General Practitioners and Community Pharmacists.

Source:

* MHRA, Safety Warnings, Drug Alerts, June 2, 2010.

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June 1, 2010

Allergy Alert: Bluebird Light Plus Potato Chips

Product Description:
Bluebird Light Plus Sea Salt Potato Chips 150g

Identification:
Best Before: 25 August 2010

NZ Distribution:
Supermarkets and Dairy's throughout the North Island.

Reason for Recall:
Undeclared Allergens - Milk, Soy & Gluten

Comments:
Bluebird Light Plus Sea Salt Potato Chips (150g bags) displaying Best Before date 25 August 2010 should not be consumed due to the presence of undeclared allergens – milk, soy and gluten.

There have been no reports of illness, however any person concerned about their health should seek medical advice.

Customers should return this product to their retailer for a full refund or phone Bluebird Foods Ltd on 0800 762 324 with any queries.

Source:

* Food Safety Authority, New Zealand, June 1, 2010.

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