Author: Phyllis Entis

Recalls and Alerts: November 27, 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.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

For current information on international and retail distribution of peanut butter products recalled due to Salmonella Bredeney, please consult the Trader Joe’s/Sunland Peanut Butter Recalls tab.

United States

  • Food Safety Recall: Capital City Fruit, Inc. (Norwalk, IA) recalls Capital brand Cherry Tomatoes (1 pt clamshell pkg; Supplied by Rio Queen Citrus, Inc.; Case Lot Nos. P96290001, P96330002, P96477001, P96368001, P96500001, P96313001, P96330007, P96290006, P96500006; Clamshell Date codes 4604, 4605, 4606, 4605, 4701, 4604, 4605, 4604, 4701), because the product may be contaminated with Salmonella. The recalled product was sold in retail stores in Iowa, Missouri, Illinois, Kansas, Nebraska, South Dakota, Minnesota and Wisconsin.
  • Outbreak Alert: The Illinois Dept. of Public Health and the McLean County Health Department are investigating a cluster of instances of Salmonella Stanley infections among individuals who reported eating at a variety of restaurants in Central Illinois from October 18th through November 11th. Transmission appears to be due to human contact, and the cases may be connected to a McDonalds franchise on South Main Street, Bloomington. The franchise owners have temporarily closed this McDonalds location, and employees of the location are being tested for Salmonella carriage.
  • FDA Warning Letter: FDA warns The Santa Barbara Smokehouse, Inc. (Santa Barbara, CA) that an April-May 2012 inspection of the company’s seafood processing facility found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and the Current Good Manufacturing Practice regulation for foods.
  • FDA Warning Letter: FDA warns Jroll L.L.C. dba Sushi On The Roll (Medina, OH) that a September-October 2012 inspection of the company’s seafood processing facility found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
  • FDA Warning Letter: FDA warns Derek and Constance Lee Corporation d.b.a. Great River Food (City of Industry, CA) that a September 2012 inspection of the company’s seafood processing facility found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and the Current Good Manufacturing Practice regulation for foods.
  • FDA Warning Letter: FDA warns Shinhan F&B Co. Ltd (Republic of Korea) that a May 2012 inspection of the company’s seafood processing facility found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

Canada

  • Allergy Alert: Soloway Hot Dog Factory Inc. (Toronto, ON) recalls Halal Beef Hot Dogs, prepared for Corsetti Meat Packers Ltd. (Ontario Plant #6472; vacuum packages contain 10 pieces; sold at CMP Meats retail store) due to the presence of undeclared mustard.
  • Allergy Alert: Purity Factories Ltd. recalls Lees’ brand 6 Snowballs (125g; Codes 01 FEB 13 B23 and 10 MAY 13 DB38; UPC 0 57858 08012 8), due to the presence of undeclared sulphites. The recalled product was sold in retail stores in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Quebec, and Saskatchewan.

Europe

Asia, Africa and the Pacific Islands

  • Outbreak Alert (Hong Kong): The Centre for Health Protection is investigating two suspected food poisoning cases involving a total of eight persons, all of whom ate at the same restaurant in Tsim Sha Tsui on November 18th and November 23rd.
  • Dietary Supplement Safety Alert (Hong Kong): The Department of Health warns members of the public not to buy or consume the slimming product known as Aulura Energy Balance Dietary Supplement, as it may contain the undeclared and banned Western drugs sibutramine and phenolphthalein.

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 Suspends Sunland’s Food Facility Registration

The agency’s action, taken under authority conferred on FDA by the Food Safety Modernization Act (FSMA), follows on the heels of a determination that “…food manufactured, processed, packed, received, or held by [the] facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and that [the] facility created, caused, or was otherwise responsible for such reasonable probability.”

Peanut butter manufactured in Sunland, Inc.’s Portales, New Mexico facility was responsible for at least 41 cases of Salmonella Bredeney infections in 20 US states, according to CDC’s most recent update, published on November 8th. Ten of the 41 outbreak victims were hospitalized.

In announcing this first ever use of FDA’s suspension powers under FSMA, the agency released the following statement:

In the interest of protecting public health, the U.S. Food and Drug Administration suspended the food facility registration of Sunland Inc., a producer of nuts, and nut and seed spreads.  Registration with the FDA is required for any facility that manufactures, processes, packs, or holds food for consumption in the United States.  If a facility’s registration is suspended, that facility is prohibited from introducing food into interstate or intrastate commerce.

The fact that peanut butter made by the company has been linked to an outbreak of Salmonella Bredeney that has sickened 41 people in 20 states, coupled with Sunland’s history of violations led FDA to make the decision to suspend the company’s registration.  

This was the FDA’s first use of its registration suspension authority, under the Food Safety Modernization Act. This new authority enables the agency to take this action when food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met.

A review of Sunland Inc.’s product testing records showed that 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012.  Between March 2010 and September 2012, at least a portion of 8 product lots of nut butter that Sunland Inc.’s own testing program identified as containing Salmonella was distributed by the company to consumers.    

Additionally, during its inspection of the plant in September and October 2012, the FDA found the presence of Salmonella in 28 environmental samples (from surfaces in production or manufacturing areas) and in 13 nut butter product samples and one product sample of raw peanuts.  Four of the peanut butter product samples showed the presence of the outbreak strain of Salmonella Bredeney.   

The suspension order offers Sunland, Inc. the opportunity to request an informal hearing on certain issues related to the order.  If, after providing this opportunity, the FDA determines that the suspension remains necessary, the FDA will require Sunland, Inc. to submit a corrective action plan to address the immediate problems and to implement a sustainable solution to those problems in a sound scientific manner.  The FDA will reinstate Sunland, Inc.’s registration only when FDA determines that the company has implemented procedures to produce safe products.

In its letter of notification to Sunland’s President, FDA referred to a number of conditions and company actions that formed the basis for its decision, including:

  • Investigation by CDC and FDA of a multistate outbreak of Salmonella Bredeney led to a determination that Trader Joe’s™ brand Valencia Creamy Salted Peanut Butter made with Sea Salt was the likely source of the outbreak;
  • Sunland was the sold manufacturer of the implicated peanut butter;
  • Evidence collected by FDA in response to the outbreak, including the company’s own testing records, environmental and finished product samples analyzed by FDA and observations made during FDA’s inspection of the facility established that nut butter and nut products manufactured, processed, packed and held by Sunland are contaminated with Salmonella or are at risk of contamination with Salmonella;
  • Sunland’s own testing records revealed that third party testing identified the presence of Salmonella spp. in at least 40 finished products from 11 finished product lots and eight sets of environmental samples between June 2009 and September 2012; and
  • Sunland distributed at least a portion of eight lots of peanut and almond butter between March 1, 2010 and September 2012 after composite testing revealed the presence of Salmonella.

The complete text of the letter can be found on FDA’s website.

Sunland’s quality assurance philosophy clearly was “keep testing until we get a Salmonella-negative result; then ship the product.” This is an approach that has been adopted all too frequently in the food industry. I have encountered it in Canada; I have encountered it in the US. It is ethically incorrect. It is scientifically incorrect.

In a word, it is WRONG.

Ranbaxy Recalls Generic Lipitor (Atorvastatin)

Ranbaxy Pharmaceuticals Inc. has initiated a recall of certain batches and strengths of Atorvastatin calcium tablets – the company’s generic version of Lipitor. The recall only affect products distributed in the United States.

The recall notice posted on Ranbaxy’s web site reads as follows:

Atorvastatin Recall

Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall only in the U.S. healthcare system for select batches and strengths of Atorvastatin calcium tablets. The recall is in connection with its 10mg 20mg and 40mg dosage strengths, packaged in 90’s and 500 count bottles, and only with respect to certain select lot numbers. The recall does not affect or relate to the 80mg strength or any other Ranbaxy Product in any other market.

The recall is being conducted in the U.S. at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the U.S. FDA. The recall is limited to the U.S. market only and affects specific lots numbers and strengths of this molecule manufactured by Ranbaxy only for sale in the U.S.

Atorvastatin calcium tablets or any other product containing this molecule distributed outside the US is not affected in any way by this recall. The activities taking place in the U.S. will not affect Ranbaxy’s ability to continue to supply product in any other markets.

Individuals who have been prescribed atorvastatin calcium in the 10mg, 20mg or 40mg dosage strengths should refer to the list of recalled products supplied by Ranbaxy, and should contact their pharmacist for additional instructions.

Three of Ranbaxy’s manufacturing facilities have been operating under a consent decree of permanent injunction, filed by the US Department of Justice in January 2012. The consent decree addressed “…outstanding current good manufacturing practice (CGMP) and data integrity issues at Ranbaxy’s Paonta Sahib, Batamandi and Dewas, India facilities as well as CGMP issues at Ranbaxy Inc.’s wholly owned subsidiary Ohm Laboratories facility located in Gloversville, N.Y.” When queried by eFoodAlert today about this recall, Sarah Clark-Lynn of FDA’s Office of Public Affairs responded with the following statement:

First, let me say that consumers in this country expect and deserve safe, effective, and high quality medications. The FDA is working with the company to address their quality issues.

Product from the affected lots of atorvastatin (see Ranbaxy’s website for the lot numbers) may have been dispensed to patients and may have already been consumed. Patients concerned about the product they have on hand should contact their pharmacist and consult with their physician.

The FDA is currently working with other manufacturers to address any potential shortage as a result of the ongoing recall. We will continue to monitor this situation.

The Ranbaxy facilities involved in manufacturing atorvastatin were not the same facilities whose conduct gave rise to the consent decree. Nonetheless, the consent decree provides the FDA with additional tools to address violations for other Ranbaxy facilities.

The evaluation of this quality issue is ongoing.