Category: Salmonella

Recalls and Alerts: February 25, 2013

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 up-to-date information on recalls and product withdrawals associated with the horse meat investigation, please consult the Horse Meat Synopsis and Recalls page.

For up-to-date information on recalls and product withdrawals associated with the Kasel pet treat recalls and investigation, please consult the Kasel Dog Treat Recalls: 2012-2013 page.

United States

  • Food Safety Recall: Ingles Markets Inc. recalls Laura Lynn Macaroni (16 oz; Item #97987), due to possible infestation.
  • Food Safety Recall: Altiza Inc. (Chula Vista, CA) recalls Malichita brand Cucumbers (44 lbs/box; Lot #MA012304), due to possible Salmonella contamination. The recalled product was distributed in California.
  • Food Safety Recall: Hoop Nuts LLC, dba Christophers Nut Co. (Van Nuys, CA) recalls ARO Pistachio/Orandi Farms Pistachio Halves ‘n’ Pieces raw pistachios (30-lb boxes; Lot #121203) due to Salmonella contamination. The recalled product was distributed in California.
  • Food Safety Recall: Hoop Nuts LLC, dba Christophers Nut Co. (Van Nuys, CA) recalls ARO Pistachio / Orandi Farms Pistachio Halves ‘n’ Pieces dry roasted pistachios (30-lb boxes; Lot #1-121213), due to Salmonella contamination. The recalled product was distributed in California.
  • Dietary Supplement Safety Recall: Olaax Corp recalls Maxiloss Weight Advanced Dietary Supplement softgels (3 x 12 blister packs per box; Batch #001; All lots) due to undeclared sibutramine. The recalled product was distributed nationwide from January 2011 to November 2012. The product was sold to distributors nationwide and known-to-be counterfeit versions are sold on various online sites. The recall includes ALL authentic Lot numbers and known to be counterfeit lot numbers of authentic lots. Any packaging types that are different from listed are counterfeit. Any lot numbers not listed are counterfeit and are also part of the recall.
  • Pharmaceutical Product Safety Recall/Alert: Affymax, Inc. and Takeda Pharmaceutical Company Limited recall OMONTYS® (peginesatide) Injection (10mg Multi-dose vials and 20 mg Multi-dose vials; All lots) after receiving postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis. The recalled product was distributed Nationwide, including Puerto Rico and Guam to dialysis centers via specialty distributors. FDA has been notified by Affymax of 19 reports of anaphylaxis from dialysis centers in the USA, including three fatal cases.

Canada

  • Allergy Alert: Sweet Revenge Confection Company recalls Barr’s Dark Almond Bark (350g; All codes; UPC 7 79781 70211 2) and Barr’s White Almond Bark (350g; All codes; UPC 7 79781 70206 8), due to undeclared peanut. The recalled products were sold in Saskatchewan.
  • Allergy Alert: Canada Volumes Import/Export Inc. recalls James Bun Frozen Golden Shine Pastry Sheet (7.02 kg; Lot No. CV21323) and James Bun Golden Shine Puff Pastry Sheets (585g; UPC 6 81240 00015 1), due to undeclared milk. The recalled products were distributed to retailers, hotels, restaurants and institutional customers in Alberta and British Columbia.
  • Allergy Alert: Unfi Canada Inc. recalls J1 Crunchy Rice Roll Black Pearl Rice & White Rice (100g; All codes; UPC 6 78108 20405 9) and J1 Crunchy Rice Roll Brown Rice & White Rice (100g; All codes; UPC 6 78108 20401 1), due to undeclared gluten. The recalled products were supplied to retailers in Manitoba, New Brunswick, Nova Scotia, Ontario, and Quebec.
  • Food Safety Recall: CFIA warns the public not to consume Murchie’s Lemon Drop Tea (25 tea bags/56g; Batch code 615125; UPC 0 67421 31025 5) and Co-Op Gold Organic Pomegranate White Tea (20 tea bags/40g; BBD: 2014JA26 and 2014MA26; UPC 0 57316 14280 1) due to possible Salmonella contamination. The recalled products were distributed in Alberta, British Columbia, Manitoba, Ontario, and Saskatchewan

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 website.

*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.

Kasel Inspection Report: Roaches and Rodents and Filth. Oh My!

FDA has released its Inspectional Observations report (Form 483) covering the issues encountered during the agency’s September 19 – 28, 2012 inspection of the Kasel Associates Industries, Inc. manufacturing plant in Denver.

Last week, Kasel recalled a range of pet treats manufactured from April 20, 2012 through September 19, 2012 due to potential Salmonella contamination. As I reported yesterday, FDA found 14 different Salmonella strains in finished product and environmental swab samples taken at the company’s manufacturing facility during the September 2012 inspection.

FDA’s 9-page report documents improper sanitation throughout the facility, inadequate pest control – including live and dead cockroaches, rodent droppings, flies and a dead mouse – improper food storage, improper handling of work-in-progress, and inadequate maintenance. Following is just a sampling of the deficiencies:

OBSERVATION 1. Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food–contact surfaces, and food-packaging materials.

  • Food debris build-up on and underneath conveyor belts on packing lines
  • Food and grease build-up on metal crates used to hold finished product before packaging
  • Finished, unpackaged bulk product stored in grease-laden and reused cardboard totes
  • Floor fan with accumulated dust and grease was blowing onto uncovered bulk bins of unpackaged finished product

OBSERVATION 2. Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.

  • Larvae-like inspects on floor drain of Cutting Room
  • Live and dead cockroaches in numerous areas, including the Packaging Room, Bulk Storage Room and Preparation Room
  • Large flies (live and dead) in the Packaging Room
  • Dead mouse in Bulk Storage Room partially under pallet of finished product
  • Rodent excreta pellets in the General Storage Room near pallets of finished/packaged products

OBSERVATION 3. Failure to take effective measures to protect against the inclusion of metal and extraneous material in food.

  • No functioning metal detector on packaging lines
  • Wooden pallets with chipping wood and loose nails stored directly on top of uncovered bulk bins of finished product
  • Metal fragments in direct contact with chicken chips on drying racks

OBSERVATION 4. Failure to take effective measures to protect finished food from contamination by raw materials.

  • Plastic tubs used in both raw production and finished product packaging to hold both raw and finished product; no system in place to differentiate which tubs were used for which purpose
  • No dedicated washing equipment or system to wash, rinse and sanitize the plastic tubs

OBSERVATION 5. Failure to store finished food under conditions that would protect against physical and microbial contamination.

  • Finished product stored uncovered in bulk bins
  • Finished product stored in unlined wire bulk crates in direct contact with floor

OBSERVATION 6. Failure to handle work-in-progress in a manner that protects against contamination.

  • Uncovered pallet of frozen chicken stored on loading dock while employees loaded a truck with loading dock door open
  • Floor sanitizer foam sprayer (label states chemical unfit for human or pet consumption) observed spraying onto uncovered bulk pallet of frozen chicken chips

OBSERVATION 7. Failure to maintain buildings, fixtures, and physical facilities in repair sufficient to prevent food from becoming adulterated.

  • Floors not sealed: grease accumulation in cracks and exposed concrete, visible chipping paint
  • Broken, taped and swollen ceiling tiles above filling lines and throughout Packaging Room
  • Broken and missing light shields
  • Hand sinks in Preparation Room not functioning

OBSERVATION 8. Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.

  • Employees observed not washing hands after leaving rest room or break room

Is it any wonder that Salmonella ran rampant throughout this facility?

FDA Flexes Muscles To Achieve Kasel Pet Treat Recall

The extensive ‘voluntary’ pet treat recall announced on February 19th by Kasel Associated Industries (Denver, CO) was triggered by FDA’s threat to invoke its new mandatory recall authority, according to Siobhan DeLancey, spokesperson for FDA’s Office of Foods and Veterinary Medicine.

Earlier today, DeLancey informed eFoodAlert by email that Kasel chose to voluntarily recall its products upon receipt of a “last chance” letter from FDA (formally, a Prehearing Order to Cease Distribution and Give Notice, also referred to as a 423(a) letter). This is the first time that FDA has initiated mandatory recall proceedings under the authority granted to it by the Food Safety Modernization Act.

FDA inspected Kasel’s manufacturing facility during a 10-day period beginning September 19 2012, after the Colorado Department of Agriculture found Salmonella in a finished product sample of Boots & Barkley 6-count 5-inch American Beef Bully Sticks. Kasel recalled four lots of the product on September 21st (Lots #BESTBY20APR2014DEN, BESTBY01JUN2014DEN, BESTBY23JUN2014DEN, and BESTBY23SEP2014DEN). On October 2nd, the company recalled Nature’s Deli Chicken Jerky Dog Treats (2.5 lb; Lot #BEST BY 091913 DEN) after FDA found Salmonella in a sample of this lot code. Additional testing carried out by Colorado prompted a third recall on October 17th, this time of Boots & Barkley Roasted American Pig Ears and Boots & Barkley American Variety Pack Dog Treats (Lot #BESTBY 13SEP2014DEN for both products). Colorado found Salmonella in another retail sample of Nature’s Deli Chicken Jerky Dog Treats (Lot #BESTBY061913DEN) in November 2012; however, Kasel refused to initiate another recall.

The September 2012 inspection carried out by FDA revealed several sanitary issues, including live insects and evidence of rodent activity in the manufacturing facility, DeLancey said. Furthermore, FDA recovered Salmonella from all of the finished product samples collected during its inspection, as well as from 1 out of 2 in-process bulk product samples and 48 of 87 environmental swab samples. Some of the Salmonella-positive swab samples were taken from food contact surfaces. In all, FDA found 14 different strains of Salmonella: Anatum,  Mbandaka,  Senftenberg,  Typhimurium, Agona,  Muenchen, Irumu,  Tennessee, Montevideo, Infantis, Muenster, Derby, O rough;d;e,n,x,  and London. Isolates recovered from products made on June 19th matched those from September 19th, indicating an ongoing contamination issue.

FDA carried out a follow-up inspection on February 14, 2013, including additional finished product and environmental swab sampling. Results of those samples are still pending; however, FDA noted that the company had taken several corrective measures.

I found it strange that the latest recall covered only the period from April 20, 2012 through September 19, 2012. DeLancey explained that this was the time frame during which positive results were collected. If FDA finds additional Salmonella-positive samples as a result of its follow-up inspection, I would expect either an expansion of the most recent recall or – in the event that Kasel proves recalcitrant – another FDA-issued warning.

FDA has received a “small number” of complaints from pet owners whose dogs became ill after being exposed to the recalled treats. No human illnesses have been reported yet.

eFoodAlert Advice to Consumers

  • Check your supply of pet treats against the products listed in the most recent recall notice. Discard any that are mentioned on the list. If you are not sure of the origin or lot code of the treat, discard it.
  • If your dog develops symptoms of a Salmonella infection (typically diarrhea or vomiting) after consuming a Kasel-manufactured treat, seek veterinary attention; also, report the illness to FDA.
  • If you or a family member develop symptoms of a Salmonella infection after handling a Kasel-manufactured pet treat – or a sick pet – seek medical attention, and mention the possible link to the pet treat.
  • Always wash your hands immediately after handling any pet food or pet treat, especially one of the affected brands listed in the recall notice.

If you believe that your pet or a member of your household has become ill as a result of exposure to one of the brands of pet treat mentioned in the recall notice, please post a comment.