Tag: Trader Joe’s

Recalls and Alerts: November 30, 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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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

  • Allergy Alert: Tri City Cheese and Meats (Kawkawlin, MI) recalls Troll Smokehouse Fully Cooked Jalapeño Vienna sausage products ( 1- and 2.5-lb Cryovac bags; Est 32015; Sell by 12/17/12 through 01/03/13), because they contain undeclared monosodium glutamate (MSG). The recalled product was distributed to retail establishments in Michigan.
  • Food Safety Recall: Veggie Patch recalls Veggie Patch Ultimate Meatless Burgers (9 oz; UPC 61012900211; Sell by date January 12, 2013), because of possible contamination by Listeria monocytogenes. The recalled product was sold at Stop & Shop, Giant Food Stores, Martin’s, and Giant of Maryland stores.
  • Food Safety Recall: Food City advises its customers that Hillshire Lil Smokies (12-14 oz) have been recalled. No additional information was provided by the retailer.
  • Outbreak Alert Final Update: CDC reports that the Salmonella Bredeney outbreak associated with contaminated peanut butter manufactured by Sunland, Inc. (Portales, NM) appears to be over. In total, 42 people were infected with the outbreak strain in 20 states. Ten people were hospitalized. FDA has suspended the company’s food facility registration, prohibiting Sunland from introducing food into commerce in the USA.

Canada

  • Allergy Alert: Pure Indulgent Foods Inc. recalls Flats by Pure Apricot Pecan Unique Savory Baked Crackers (170g; Code 5/30 13; UPC 8 73376 00303 2), because the product contains undeclared sulphites. The recalled product was sold through retailers in Alberta, British Columbia and Ontario.
  • Food Safety Recall: ERAA Supermarket Inc. recalls ERAA Jaggery Lump Brown Sugar (900g; Batch 06/12; Best before AUG 2013; UPC 8 901792 100911 and 8 901792 101321), due to contamination with unspecified extraneous material. The recalled product was sold through retailers in Ontario.

Europe

  • Allergy Alert (Ireland): Food Safety Authority of Ireland warns consumers that Kupiec corn flour “gluten free” (400g; Product of Poland; Batch B184 PL; Best before 31/01/2013) was found to contain undeclared gluten. The product, which is known in Polish as Maka Kukurydziana, has been sold in stores across Ireland, mainly those selling Eastern European foods.
  • Food Safety Recall (France): SARL Fontanilles recalls Charcuterie Fontanilles brand of meat-based canned deli products (Expiry 2016), due to lack of product stability. The recalled products were sold in the département of Tarn after May 23, 2012. Please refer to the recall notice for a list of retailers that carried the recalled products.
  • Food Safety Recall (Switzerland): La fromagerie Moléson recalls Le Capriglânois soft curd goat cheese, made from raw milk (80g; Lot # L224703 / L224935 / L225166 / L225436 / L226154; Expiry dates 6.12.2012 / 7.12.2012 / 10.12.2012 / 11.12.2012 / 14.12.2012), after Listeria monocytogenes was found in the product.
  • Outbreak Alert Update (Norway): The number of illnesses due to Salmonella Mikawasima has risen to 12 cases in nine counties, including Oslo (1 patient) Akershus (1), Vestfold (1), Aust-Agder (1), Vest-Agder (3) Telemark (1), Oppland (1 ), Hordaland (2) and Nordland (1). All of the affected individuals are adults, most of them aged 20 – 50 years. Norway’s Public Health Institute is continuing its investigation into the source of the outbreak.
  • Food Safety Notification (EU #2012.1658): Listeria monocytogenes in gorgonzola and mascarpone cheese cake from Italy; distributed to Germany, Italy and the Netherlands.
  • Food Safety Notification (EU #2012.1659): Sulfathiazole and sulfadimidine in forest honey from Poland; distributed to Slovakia.
  • Food Safety Notification (EU #2012.1660): Mercury in frozen slices of swordfish from Spain; distributed to Italy.
  • Food Safety Notification (EU #2012.1661): Mercury in frozen sword fish from Spain; distributed to Germany and Italy.

Australia and New Zealand

  • Food Safety Recall (Australia): Delin (Australia) Trading Pty Ltd. recalls Favor Swallow Bean Sauce (350g glass jar; Best before 18/09/14; Product of China) due to contamination with Bacillus cereus. The recalled product was sold in some Asian supermarkets in Victoria only.
  • Outbreak Alert (New Zealand): The New Zealand Herald reports that a ward has been closed at Hawke’s Bay Hospital due to an outbreak of vomiting and diarrhea among staff and patients. Visitors have been urged to stay away.

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.

Sunland vs. FDA: Who Should We Believe?

At no time in its twenty-four year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms.

– Jimmie Shearer, President and CEO, Sunland, Inc.

On November 14, 2012, FDA issued the following update to its investigation of the Salmonella Bredeney peanut butter outbreak.

“November 14, 2012 – FDA posts observations from recent inspection at Sunland Inc.  

The FDA has made the observations from its recent inspection of Sunland Inc. publicly available.  This inspection was conducted between September 17 and October 16, 2012, and became part of the investigation of the Salmonella Bredeney outbreak linked to peanut butter made by Sunland Inc.

During this inspection investigators found that conditions in the company’s facility, the company’s manufacturing processes, and the company’s testing program for Salmonella may have allowed peanut butter that contained Salmonella to be distributed by the company.  

The FDA found that between June of 2009 and August of 2012, Sunland Inc. had distributed, or cleared for distribution, portions of 11 lots, or daily production runs,  of peanut or almond butter after its own testing program identified the presence of at least one of nine different Salmonella types (Arapahoe, Bredeney, Cerro, Dallgow, Kubacha, Mbandaka, Meleagridis, Newport, and Teddington) in those lots.  Two of these lots showed the presence of the outbreak strain of Salmonella Bredeney.  

Equally important, five product samples collected and analyzed by FDA from Sunland Inc. showed the presence of Salmonella, but had not been identified as containing Salmonella by Sunland Inc.’s internal testing.  Among those products were peanut butter and shelled raw peanuts.  Two of these samples showed the presence of the outbreak strain of Salmonella Bredeney.  

Additionally, during its inspection of the plant in September and October 2012, the FDA found the presence of Salmonella in 28 environmental samples.  Three of these samples showed the presence of the outbreak strain of Salmonella Bredeney.  

Upon identifying the contaminated peanut butter, FDA investigators informed the company and called for corrective action.  On October 4, 2012 Sunland Inc. expanded its ongoing recall to include all products made in the Sunland Inc. nut butter production facility between March 1, 2010 and September 24, 2012.  

Upon identifying the contaminated shelled raw peanuts, FDA investigators informed the company and again called for corrective action.  On October 12, 2012 Sunland Inc. expanded its ongoing recall to include raw and roasted shelled and in-shell peanuts sold in quantities from 2 ounces to 50 pounds which are within their current shelf life or have no stated expiration date.   

Additionally, investigators found that employees improperly handled equipment, containers, and utensils used to hold and store food. Employees handling peanut products wiped gloved hands on street clothes and other times failed to wash their hands or change gloves. There were no hand washing sinks in the peanut processing building production or packaging areas and employees had bare-handed contact with ready-to-package peanuts.  

There were no records documenting the cleaning of production equipment.  The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts.  There was a leaking sink in a washroom which resulted in water accumulating on the floor, and the plant is not built to allow floors, walls and ceilings to be adequately cleaned.  

Finally, investigators found that raw materials were exposed to potential contamination.  Raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for Salmonella and other bacteria.  Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.  

The FDA is currently evaluating Sunland Inc.’s official response to FDA’s observations from the inspection.”

Yesterday – November 15th – Sunland responded with this statement:

“At no time in its twenty four year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms.  The Company has followed internal testing protocols that it believed resulted in the isolation and destruction of any product that did not pass the test designed to detect the presence of any contaminants.  In every instance where test results indicated the presence of a contaminant, the implicated product was destroyed and not released for distribution.  The Company believed at all times that its response was sufficiently robust such that any product which might be contaminated was isolated and destroyed. 

Sunland, Inc. continues to cooperate openly with FDA to address matters related to the recent recall of its products and the inspection of its manufacturing facilities.  Sunland has submitted a comprehensive point by point response to the Form 483 observations issued at the close of the inspection.  The Company’s response is currently under review by the agency.  We believe that drawing any inferences much less conclusions about the Company’s practices based solely on the observations as set forth in the Form 483 without considering the Company’s response would be wholly premature and unduly prejudicial to Sunland.  The Company believes that its response to the Form 483 will not only help the agency understand the Company’s decision-making process but also lead the agency to confirm that such decision-making was, at all times, conducted in good faith.  In deference to the agency’s review process, the Company will not publicly discuss its responses until the agency has completed its review.”

Sunland has not denied that contaminants were found. Nor has it denied that multiple strains of Salmonella were present at various times and in various locations, in its finished products, its raw peanuts, and its production environment.

How does a food processor allow this magnitude of contamination to exist in its finished products and in its production facility for more than three years? What does this say about the ethics of the company’s owners and management?

Or has ethical behavior become an oxymoron in the food industry?