Author: Phyllis Entis

Recalls and Alerts: April 26, 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: Reser’s Fine Foods, Inc. (Beaverton, OR) recalls Mrs. Weaver’s Pimento Spread (7 oz; Use by Aug/05/12; Plant ID & Time 20 HH:MM; UPC 71117.00003), because the spread may have been packaged into containers marked Ham Salad. The Ham Salad label does not list milk as an ingredient. The recalled spread was distributed in AR, AZ, FL, LA, MS, OK, TX, and WA between April 11, 2012 and April 17, 2012.
  • Allergy Alert: Krispak, Inc. (Grand Rapids, MI) recalls GFS® Hostess Candy Mix (8-48 oz packages; Code date 088 12), because some of the cases of Candy Mix were inadvertently put into GFS® Chocolate Sprinkles packages, which do not declare the ingredients wheat, milk and egg, all of which may be present in the Candy Mix. The affected product wasdistributed between April 5th and 19th to Indiana, Ohio, Michigan, Kentucky, Pennsylvania, and Tennessee Gordon Food Service Marketplace Stores.
  • Food Safety Recall: LA Star Seafood Co. Inc. (Los Angeles, CA) recalls Vobla Dry fish and Vobla Smoked fish (20-lb bulk boxes; no lot numbers or expiry dates), because the fish were improperly eviscerated and, therefore, have the potential to be contaminated with Clostridium botulinum. The recalled products were distributed and sold at: Arbat Store, Utah; European Importing, Russian Import, and M and M Market, Northern California; Golden Farms Market, Karabagh Market, and Tashkent Market, Southern California; Global Importing, Oregon; Solomon’s Groceries and Europa, Colorado between February 28th and April 23rd, 2012.
  • Pet Food Safety Recall: Diamond Pet Foods recalls Chicken Soup for the Pet Lover’s Soul Dog Food (“certain lots” – to be updated) after lab tests conducted by the Ohio Department of Agriculture found Salmonella in a sample of the pet food
  • Pharmaceutical Product Safety Recall: American Regent recalls Epinephrine Injection, USP, 1:1000 (1mL ampules; Lot #1395; Expiry July 2012), due to the presence of discoloration and small visible particles in some ampules. The recalled product was wholesalers and distributors nationwide. Hospitals, Retail Pharmacies, Clinics, Physician Offices, and other healthcare facilities and providers are instructed to stop using the recalled batch of product and immediately quarantine any outstanding supply of Lot #1395 for return.

Canada

  • Allergy Alert: Le Grand Marché Col-Fax inc (Laval, QC) recalls a number of pastries and prepared foods (sold up to and including 23 April 2012), due to the presence of undeclared soy and/or sulfites. Please refer to the recall notice for a list of affected products.
  • Allergy Alert: Transhing Investment Inc. (QC) recalls Koh-Kae Peanuts with Thai Tom Yum Spicy Flavour Coated (230g; All codes; UPC 8 852023 666549) due to the presence of chemical additives and undeclared shellfish and milk. The recalled product was sold in Ontario and Quebec.
  • Allergy Alert: Bramic Sales recalls Koh-Kae Peanuts Tom Yum Flavour Coated (240g; All codes; UPC 8 852023 666549), due to the presence of chemical additives and undeclared shellfish. The recalled product was sold in Manitoba, Nova Scotia, Ontario and Quebec.
  • Food Safety Notification (EU #2012.0586): Listeria monocytogenes in raw milk sheep cheese coated with herbs from France; distributed to Austria, Belgium, Canada, Denmark, France and Germany.

Europe

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.

Wisconsin Ag Lab Finds Salmonella Bareilly In Recalled Tuna

Wisconsin’s Department of Agriculture Trade and Consumer Protection lab has recovered Salmonella from a sample of recalled tuna and from a spicy tuna roll made with the recalled tuna. The state’s Laboratory of Hygiene confirmed that the Salmonella found in both of these samples matches the DNA fingerprint of the outbreak strain of Salmonella Bareilly that has sickened more than 160 people in 20 states and the District of Columbia.

Moon Marine USA Corporation recalled 58,828 lbs of Nakaochi Scrape AA or AAA – a frozen raw yellowfin tuna product – on April 13th after epidemiological and traceback investigations carried out by federal, state and local authorities linked the product to a multistate outbreak of Salmonella Bareilly illnesses. The raw tuna product, which resembles ground tuna, was imported into the USA from India. FDA also issued two Import Alerts (#16-81 and #16-133) authorizing the detention without physical examination of fresh and frozen tuna from Moon Fishery India Pvt Ltd, the producer of the contaminated tuna meat.

The recalled product was not distributed for retail sale to consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores. While the company name and “Nakaochi Scrape AA or AAA were printed on boxes of product supplied to distributors, the tuna may not be readily identifiable by consumers as being from implicated lots.

News of the Salmonella Bareilly outbreak first broke on April 3rd. As of the CDC’s last update (April 20th), 26 people are known to have been hospitalized out of the 160 confirmed case patients. Reported onset dates for illnesses range from January 28th to April 10th. The youngest outbreak victim is 4 years of age; the oldest is 78 years old. Two-thirds of the confirmed case patients are female.

Confirmed cases of Salmonella Bareilly illnesses have been reported mainly from the eastern half of the continental USA; the westernmost cases are in Texas. Wisconsin has confirmed 15 cases in three counties, including Milwaukee (6 cases), Washington (2 cases) and Waukesha (7 cases). Three Wisconsin residents were hospitalized; all 15 have recovered from their illnesses.

FDA has this advice for consumers:

  • Because raw seafood is not fully cooked to assure that pathogens are destroyed, it is not considered as “safe” as cooked seafood. The handling of raw seafood can also affect the safety of the product. Because the tuna may have been broken into unmarked sublots and may not be readily identifiable, consumers should take precautions in choosing to eat raw Nakaochi Scrape and be sure that it is not from the implicated lots.
  • If you purchase “spicy tuna” or other sushi, sashimi, ceviche, or similar dishes that might contain Nakaochi Scrape from a restaurant or grocery store, check with the establishment to make sure that it does not contain raw recalled product from Moon Marine USA Corporation, also known as MMI. When in doubt, don’t eat it.
  • Consumers who think they might have become ill from eating possibly contaminated raw Nakaochi Scrape should consult their health care providers.

Excedrin Return Still Months Away

Novartis hopes to gradually restart production at its Lincoln, Nebraska manufacturing plant as early as May, and resume shipping some products at mid-year. But a return to full production will probably not happen until 2013.

Production will restart on a line-by-line basis, according to David Epstein, Division Head of Novartis Pharmaceuticals, who offered a status update during the Novartis 1st Quarter 2012 Earnings Conference Call earlier today (April 24th)

“[W]e are in the middle of quality remediation activities at Lincoln,” Epstein said, “and we are making good progress. We had a meeting with the FDA recently, and shared with them our startup plan for the plant. We will begin production in May and we will resume shipments mid year.”

Epstein indicated that the “ramp up” would be slower than expected. “We’ll have a relatively limited portfolio in the back half of the year. So we have signed up some third-party manufacturers for some key products,” he explained. Neither Epstein nor any other participant in the conference call specified the order in which Excedrin and other products manufactured at that plant would reappear. Nor was there any indication as to which products would be farmed out to third-party manufacturers.

Novartis suspended production at its Lincoln facility on January 8, 2012 and recalled more than 125 million bottles of Excedrin and other OTC medications after a FDA inspection revealed flagrant and long-standing deficiencies in the company’s quality assurance and consumer complaint procedures. The shutdown of the Lincoln plant also has affected availability of a number of veterinary products, including Interceptor, a popular medication for preventing heartworm in dogs and cats.

I asked FDA for a description of the steps usually undertaken in a situation such as this one. After making the usual disclaimer that “FDA does not comment on an ongoing investigation,” Shelly Burgess of FDA’s Office of Public Affairs offered the following explanation:

“FDA investigators conduct routine inspections at drug manufacturing facilities to determine, among other things, compliance with the current good manufacturing practice regulations. When the investigator finds significant deviations from those minimum standards, he or she lists the deviations on a document called a form FDA 483, or the “483,” and issues that to the manufacturer at the conclusion of the inspection. By providing this notice, the Agency gives a manufacturer the opportunity to take voluntary and prompt corrective action. The manufacturer may submit a written response to the Agency explaining how it has corrected the violations or plans to do so, or explain why it disagrees with any of the listed observations. In most cases, manufacturers comply voluntarily but in some instances FDA sends the manufacturer a warning letter or an untitled letter. In addition, where appropriate, FDA may pursue enforcement action such as seizure and injunction.”

“The timeline can vary considerably depending on the extent of the corrective actions that are required for the firm to achieve compliance and demonstrate sufficient controls over manufacturing to produce acceptable quality drugs. Some deficiencies can be corrected within hours or days of notification such as when re-training an employee or fixing a piece of equipment. Other corrective actions may take days or months, such as qualifying a complicated manufacturing operation or validating a new test method.”

It’s not surprising that the restart in Lincoln will be slower than Novartis had originally hoped, or that the company is being vague regarding which products will receive priority when production at the facility resumes. No one wants a repeat of the problems that led to the recalls and shutdown.

Nevertheless, the delay will result in additional headaches for consumers, pharmacists, doctors, and veterinarians as the product shortages continue.