Month: January 2012

Recalls and Alerts: January 16, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

  • Allergy Alert: Ryt-way Industries LLC (Lakeville, MN) recalls BIGS Dill Pickle Sunflower Seeds (5.35 oz; Best by 08DEC2012 and 09DEC2012), due to the presence of undeclared soy. The recalled products were sold at Buehler’s Fresh Foods and Tops Friendly Markets.
  • Food Safety Recall: RSW Distributors, LLC (Forest City, NC) recalls Seasoned Cooked Beef (Diced) Manufactured by Culinary Standards (4 x 8-lb pouches; Est 8318; Produced Dec. 9, 2011), after a conveyor belt is damaged during production. There is a risk that small pieces of the damaged belt may have contaminated the recalled product, which was shipped to institutions for further distribution to schools in South Carolina, Tennessee and Washington as part of the USDA’s National School Lunch Program.
  • Consumer Product Safety Alert: Bed Bath & Beyond advises consumers to return Dual Ridge Metal Boutique tissue boxes, Model #DR9M, because the product may be contaminated with radioactive cobalt-60. The tissue boxes were sold in Bed Bath & Beyond stores in the USA and Canada since August 1, 2011.
  • Outbreak Alert: The Western Upper Peninsula Health Department (Michigan) is investigating seven cases of E. coli O157:H7 illnesses that developed during the Christmas/New Year holiday season. Four of the victims were hospitalized. The health department has determined that an ill food-handler at The Ambassador restaurant in Houghton, MI was the likely source of the outbreak.
  • Outbreak Alert Update: The norovirus outbreak linked to Bob Chinn’s Crab House in Wheeling, IL has risen to 146 illnesses.

Canada

  • Food Safety Recall: Viandes Giroux Inc. recalls Boeuf Haché Mi-Maigre (5-kg; Code #11DE21), due to contamination with E. coli O157:H7. The recalled ground beef was distributed to hotels, restaurants and institutions in the province of Quebec.
  • OTC Pharmaceutical Product Safety Recall: Novartis Consumer Health Canada Inc. recalls Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets (All lots with expiration dates of December 20, 2014 and earlier), due to reports received from the USA of chipped and broken pills and inconsistent bottle packaging clearance practices, which could result in the bottles contain foreign tablets, caplets or capsules.
  • Consumer Product Safety Recall (Update): Toy Land Company (Vancouver, BC) recalls Heart-shaped pendants and plastic plug bracelets, after Health Canada finds that the childrens’ jewellery items contain lead in excess of the allowable limit. The recalled products were imported from China and sold across canada from 2006 to 2011.
  • Consumer Product Safety Alert: Bed Bath & Beyond advises consumers to return Dual Ridge Metal Boutique tissue boxes, Model #DR9M, because the product may be contaminated with radioactive cobalt-60. The tissue boxes were sold in Bed Bath & Beyond stores in the USA and Canada since August 1, 2011.
  • Outbreak Alert: Student journalists attending the Canadian University Press’s 74th National Conference in Victoria, BC were stricken with an outbreak of nausea and vomiting during the conference. The outbreak is most likely due to Norovirus.

Europe

  • Allergy Alert (Denmark): Koh-A/S recalls Gold Vang Carrot Buns (Best before 19.01, 20.01, 22.01 and 23.01), because the product may contain traces of undeclared sesame.
  • Food Safety Recall (Germany): REWE Group recalls REWE frozen rainbow trout (500g), due to the presence of the unapproved drug, malachite green.
  • Contact Lens Safety Recall (Spain): Johnson & Johnson Medical Iberia recalls Acuvue® Oasys® (senofilcon A) contact lenses (Lot #L001RJ5/-2.00D, Lot #001RJ8/-2.75D and Lot #001RJ9/-3.00D), because the contact lenses were found to have higher than expected levels of a diluting agent.
  • Contact Lens Safety Recall (Italy): Johnson & Johnson Vision Care recalls  Acuvue® Oasys® (senofilcon A) contact lenses (Lot #L001RJ5/-2.00D, Lot #001RJ8/-2.75D and Lot #001RJ9/-3.00D), because the contact lenses were found to have higher than expected levels of a diluting agent.
  • Medical Device Safety Recall (Italy): Wright Medical Technology recalls Dynasty® Biofoam Cups due to a packaging defect that could result in contamination with polypropylene particles. Please refer to the recall notice for a detailed list of affected products.

Asia, Africa and the Pacific Islands

  • Chinese Medicine Safety Alert (Hong Kong): The Department of Health has received a report of a case of aconitum alkaloid poisoning that may be associated with the consumption of a Chinese herbal medicine. The case is under investigation.

Australia and New Zealand

  • Food Safety Recall (Australia): Gippsland Sprout Co. recalls Gippsland Sprout Co Mung Beans (200g package; Use by 15 Jan and 17 Jan) and Flowerdale Farm Mung Sprouts (200g package; Use by 15 Jan and 17 Jan), due to contamination with E. coli. The recalled products were sold through Melbourne Wholesale Fruit and Vegetable Market (Footscray), small grocery stores (including Inverloch Foodworks) and green grocers in Victoria.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

FDA Fines American Red Cross Another $9.6 Million

For the second time in less than 2 years, FDA has levied fines of more than $9 million on the Biomedical Services arm of the American National Red Cross.

The fines are due to violations by the Red Cross of a 2003 Amended Consent Decree of Permanent Injunction. FDA and the Red Cross entered into the 2003 Consent Decree after FDA inspections of various Red Cross biomedical facilities found numerous deviations from FDA law, regulations and the requirements of an earlier (1993) Consent Decree. The biomedical facilities are responsible for ensuring the safe collection, screening, handling and distribution of the nation’s supply of donated blood.

On June 17, 2010, FDA informed the Red Cross that the non-profit organization was to be fined $9,776,000 for violations of the Consent Decree that occurred from 2003 to 2008. The second series of fines, announced on January 13, 2012, covers violations that were documented during a series of inspections carried out from April 2010 through October 2010.

All told, FDA has fined the American National Red Cross $19,368,200.

A number of the violations that were documented during FDA inspections of 16 different Red Cross Blood Services facilities threaten the potential safety of the nation’s donated blood supply. Here are just a few of the more egregious lapses:

  • Failure to establish, implement and continuously maintain managerial control over QA in all regions and laboratories…
  • QA programs were not adequate to ensure that all regulated donor management operations were being performed effectively at the Philadelphia DCSC…
  • Failure to comply with reporting requirements…
  • Inadequate National Donor Deferral (high-risk donor screening) Register…
  • Failure to promptly implement adequate corrective actions to prevent recurrence of the failure to control suspected blood or blood components…
  • Failure to follow Standard Operating Procedure…
  • Failure to establish and maintain a distribution and receipt procedure that includes a system by which the distribution or receipt of each unit of blood can be readily determined to facilitate its recall, if necessary…
  • Failure to ensure that supplies are used in a manner consistent with the manufacturer’ s instructions, and failure to prepare the phlebotomy site using a method that gives maximum assurance of a sterile container of blood…

FDA also underscores in its most recent letter to Mr. Chris Hrouda, Executive Vice President of Biomedical Services for the American National Red Cross that many of the violations enumerated in the January 13, 2012 letter are “virtually identical” to violations reported in previous letters.

As of March 2010, the adult population (15 years of age and up) of the USA was approximately 242 million people. According to the Red Cross web site, 3 out of every 100 Americans – that’s roughly 7.25 million people – are blood donors. I wonder how those 7.25 million people feel about the way the Red Cross is handling their precious Gift of Life.

The American National Red Cross depends on the good will and generosity of millions of people who donate their time, money, and blood to save the lives of total strangers. It’s time that the organization was held to account, not just by FDA, but also by the people on whose generosity it relies for its very existence.

Next time the Red Cross contacts me to ask for a donation, I plan to demand an accounting of how they propose to clean up their act. I suggest that everyone do likewise.

Excedrin Recall Spills Into Canada

Novartis Consumer Health Canada Inc. has recalled two Excedrin products, according to a report released on January 13, 2012 by Health Canada.

The Canadian recall is part of a much larger recall of Excedrin, Bufferin, NoDoz and Gas-X Prevention products announced a week ago by Novartis Consumer Health in the USA. The Lincoln, Nebraska manufacturing plant where these products were made was the subject of a scathing inspection report issued by FDA in July 2011, and has been closed temporarily to allow for maintenance and improvements.

The Canadian recall encompasses all production lots of Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets (Expiration dates on or before December 20, 2014).

The recalled products were sold in Canada by Costco Canada and may also have been carried by other retail grocers, supermarkets and pharmacies.

For more information on the Novartis recalls, please select the Excedrin, Etc. Recalls tab.