JBS knowingly distributed pentobarbital-adulterated products

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission.

JBS Souderton Inc. continued to distribute pentobarbital-adulterated products to customers even after receiving formal notification of pentobarbital contamination, according to a warning letter issued on April 23 by the Food and Drug Administration.

The warning letter to JBS Souderton Inc., which does business as MOPAC, was sent more than one year after pentobarbital was first discovered in beef tallow from the company’s Souderton, PA, facility.

Pentobarbital is a barbiturate used by veterinarians to euthanize animals, including companion animals, horses and cattle. According to the FDA, pet foods containing even a trace amount of pentobarbital are considered adulterated. It is against federal law to release “adulterated” products into the stream of commerce.

JBS was the supplier of beef tallow to Big Heart Pet Brands Inc. and to Champion PetFoods, among others.

Big Heart is a wholly owned subsidiary of The J.M. Smucker Company Inc. Champion is a Canadian pet food company whose U.S. production facility is in Auburn, KY. It manufactures Acana and Orijen brands of dry dog food.

In February 2018, a media outlet reported having found pentobarbital in several samples of Gravy Train canned, wet dog food. Smucker initiated a product withdrawal of the implicated products pending the outcome of its internal investigation. 

Concurrently, FDA alerted pet owners about the possible presence of pentobarbital in the several dog food brands, including Gravy Train, Kibbles ’N Bits, Ol’ Roy and Skippy.

Smucker converted its withdrawal into a full-blown recall once company officials had confirmation of the presence of pentobarbital in its finished product and in samples of beef tallow supplied by JBS.

As part of its investigation into the Big Heart, FDA and the Pennsylvania Department of Agriculture conducted a joint inspection of JBS beginning March 13, 2018.

According to the warning letter, FDA found pentobarbital in four out of nine samples collected at the JBS facility. Upon further analysis, three of the samples were found to contain pentobarbital at levels ranging from 61.8 +/-19 to 277 +/-70 nanograms per gram (ng/g), well above the minimum detection concentration of 4 ng/g.

The four pentobarbital-contaminated products were delivered to customers from November 2017 through March 2018.

Samples collected from JBS and from its customers’ facilities and analyzed by Pennsylvania officials found levels of pentobarbital as high as 680 ng/g.

The list of Inspectional “Observations” in the FDA’s Form 483, provided to JBS management on Oct. 17, 2018, contained two items:

  1. JBS did not visually verify loads of raw materials with what the hauler stated that they brought in. This led to tallow, manufactured at [the JBS] facility, to be adulterated with pentobarbital.
  2. JBS did not have an effective system for evaluating incoming raw materials to ensure that these ingredients are suitable for use in human products and animal feeds.

JBS officials informed the FDA on April 17, 2018, that the company had completed cleaning all of its conveyances, conduits, cookers and centrifuges, and some of its storage tanks to remove any pentobarbital-contaminated product. In a May 30, 2018, letter, JBS management indicated the company would complete the cleaning process within an additional 30 days.

The company officials also reported having identified and talked with all of its suppliers that may have presented a risk for entry of euthanized animals into the rendering plant, and obtained a guarantee from each supplier that they would not provide euthanized animals. JBS also indicated it would continue to conduct random tests of tallow products for pentobarbital.

On July 27, 2018, the FDA took a follow-up sample from one of the JBS storage tanks. Upon analysis, the sample was found to contain trace amounts of pentobarbital.

On Aug. 8, 2018, the FDA inquired what actions JBS planned to take in response to the pentobarbital finding. 

The company declined to recall the product. Instead, JBS offered to ask animal food producing customers that received animal food products to remove any products deemed positive for pentobarbital and to have their tanks cleaned.

JBS described its product withdrawals and attempted withdrawals of pentobarbital-contaminated product from its customers in a Nov. 26, 2018, letter to the FDA. 

In its warning letter, the FDA noted that it was unable to asses the effectiveness of the corrective actions in the absence of a voluntary recall or other documentation demonstrating all contaminated products were removed from the marketplace.

As reported by Food Safety News in November 2018, Champion PetFoods retrieved pet foods the contaminated tallow from its third-party distributors. The company declined to initiate a retail-level recall, even though some of the product had reached the store/consumer level. The refusal was based on laboratory test results on retained samples of those finished products that did not reveal pentobarbital.

JBS was given fifteen working days to notify the FDA in writing of the specific steps it has taken to correct the violations listed in the warning letter, or to provide a time frame within which the corrections will be completed.

Recalls and Alerts: December 1 – 4, 2018

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.

United States

OUTBREAK ALERT/Food Safety Recall (Update): JBS Tolleson, Inc. expands its earlier recall to include approximately 12,093,271 pounds of non-intact raw beef products that may be contaminated with Salmonella Newport. Non-intact raw beef from JBS has been linked to a multistate outbreak of Salmonella Newport illnesses. Please refer to the recall notice for a complete list of affected products.

Canada

Food Safety Recall: Le Maître saucissier recalls SAUCE À LA VIANDE À LA MARIO CHAIR SAUCISSE (350 ml and 750 ml glass jars; all items sold up to and including 29 November 2018) because the item was not prepared and processed in a way that ensures its safety.

Europe

Allergy Alert (Belgium): PepsiCo recalls Lay’s Bugles Original (125g; Lot #22.12.18; Best before 22/12/2018) due to undeclared soy, celery, mustard, milk and lactose.

Allergy Alert (Belgium): Firma Roleski recalls Ocet – Spirytusowy 10%, Branntweinessig 10% vinegar (500 ml; Best before 21/12/2020) due to undeclared sulfite.

Allergy Alert (Denmark): DANONE Denmark recalls Oikos Stracciatella yogurt (2 x 125g; Best before 30 / 12-2018) due to undeclared milk.

Allergy Alert (Germany): Nawarra Süßwaren GmbH recalls San Fabio Amarena Cherry in Dark Chocolate (150g; Lot #L18260; Best before 17/03/2020) due to undeclared hazelnuts.

Food Safety Recall (Belgium): La société Imperial Meat Product recalls Imperial brand Pikanti dry and fermented sausages (1.2 kg; Lot #L042191; Best before 18/02/2019) due to possible Salmonella contamination.

Food Safety Recall (Belgium): La société Imperial Meat Products recalls Saint-Alby brand Jambon d’Ardenne (100g; Best before 30/11/2018, 02/12/2018, 11/12/2018, 13/12/2018, 23/12/2018, 26/12/2018, 03/01/2019, 05/01/2019, 10/01/2019, 15/01/2019, 18/01/2019) due to possible Salmonella contamination.

Food Safety Recall (Belgium): Aldi recalls Délifin brand Filet De York ultrafin (150g; Lots 4065, 4073, 4077, 4079, 4088, 4091, 4095; Best before 04/12/2018, 13/12/2018, 18/12/2018, 20/12/2018, 31/12/2018, 03/01/2019, 08/01/2019) due to possible Salmonella contamination.

Food Safety Recall (Belgium): Vleeswaren Paul Peeters et fils BVBA recalls various salami products due to possible Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Belgium): La société Imperial Meat Product recalls Marcassou brand Jambon d’Ardenne (80g; Lots L004065 – 004071 – 004079 – 004092; Best before 04/12/2018 – 11/12/2018 – 20/12/2018 – 04/01/2019) due to possible Salmonella contamination.

Food Safety Recall (Italy): La Fattoria di Parma srl recalls Salame dimezzato confezionato sottovuoto (310g; Lot #F13A18M; Best before 14/01/2019) due to deviation from microbiological standards for food safety.

Food Safety Recall (Netherlands): ALDI recalls Alsatian cervelet and pepper sausage (150g; Best before 26-11-2018 through 07-01-2019) due to possible Salmonella contamination.

Australia and New Zealand

Food Safety Recall (New Zealand): Woolworths NZ Ltd recalls Countdown brand Trevally Fillets (Best Before 16.Nov.18 to 26.Nov.18) due to elevated histamine levels.

Recalls and Alerts: November 15 – 18, 2018

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.

United States

OUTBREAK ALERT: FDA reminds parents not to feed honey to children younger than one year old. Honey Pacificers purchased in Mexico suspected in four cases of infant botulism in Texas.

OUTBREAK ALERT/Food Safety Recall: Jennie-O Turkey Store Sales, LLC recalls 91,388 pounds of raw ground turkey products due to possible contamination with Salmonella Reading. The contaminated turkey meat may be linked to a 35-state outbreak of Salmonella Reading illnesses, including one death, 164 illnesses and 63 hospitalizations.

OUTBREAK ALERT (UPDATE): CDC reports outbreak of Salmonella Newport infections linked to ground beef recalled by JBS Tolleson, Inc. has grown to 246 confirmed cases (59 hospitalized) in 25 states.

Allergy Alert: Chukar Cherries recalls Amaretto Rainier Chocolate Cherries (7.5 oz; Best By date of 09/2019; UPC 0 11261 22307 7) due to undeclared milk.

Allergy Alert: Nor Cal Food Solutions, LLC recalls Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen (7.75oz glass jars with a black metal lid; Lot codes PKPP17179A, PKPP17179B, PKPP17179C and PKPP17230B; Best before June 2019 and August 2019 (Lot code PKPP17230B)) due to undeclared walnuts.

Food Safety Recall: The Quaker Oats Company recalls 21 boxes of Cap’n Crunch’s Peanut Butter Crunch cereal (17.1 oz; Best Before JUL 30 19 or JUL 31 19; UPC 0 30000 6211 1) due to possible Salmonella contamination. The recalled product was supplied to five Target stores. Please refer to the recall notice for a list of the affected locations.

Food Safety Recall: Majestic Meat Company recalls approximately 532 pounds of bulk ground beef, ground beef patties, and meatballs due to possible contamination with E. coli O157:H7. Please refer to the recall notice for a complete list of affected products, which were shipped to restaurants in the state of Utah.

Food Safety Recall: Green Cedar Dairy recalls Green Cedar Ackawi cheese (Sell by March 26, 2019 or later) due to possible Listeria monocytogenes contamination. The recalled product was distributed at retail locations East Dearborn and Dearborn Heights Michigan.

Canada

Allergy Alert: Paradise Kosher recalls various baked goods due to undeclared wheat, gluten, eggs, sesame seeds, mustard and soy. Please refer to the recall notice for a complete list of affected products.

Allergy Alert: Industry recalls Ottogi brand Jin Ramen Spicy (600g; BEST BEFORE AUG.20.2019) and Ottogi brand Jin Ramen Mild (600g; BEST BEFORE AUG.19.2019) due to undeclared egg.

Food Safety Recall: L’Intermarché Lagoria recalls sardines due to elevated levels of histamine. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Chez Hector Prêt à manger recalls JAMBON À LA BIÈRE ET SIROP D’ÉRABLE  (500 mL; All product sold up to and including 16 November 2018) because the product may be unsafe for consumption.

Europe

Allergy Alert (Belgium): Colruyt recalls Everyday mélange à la noix muscade (100g; Lot #P101372; Best before 08/2022) due to undeclared milk and mustard.

Allergy Alert (Ireland): Allergy Alert (UK): Nisa recalls Heritage Dark Chocolate (90g; Best before 5 December 2019) due to undeclared milk.

Allergy Alert (Ireland): Clive’s recalls Clive’s Bombay Vegetables with Daal Tarts (190g; all Best before dates; All batch codes) due to undeclared mustard and sesame.

Allergy Alert (UK): Nisa recalls Heritage Dark Chocolate (90g; Best before 5 December 2019) due to undeclared milk.

Allergy Alert (UK): Clive’s recalls Clive’s Bombay Vegetables with Daal Tarts, chilled (190g; all dates up to and including 24 November 2018) and Clive’s Bombay Vegetables with Daal Tarts, frozen (190g; all dates up to and including 24 May 2019) due to undeclared mustard and sesame.

Food Safety Recall (Denmark): Salling Group recalls Bakersfield Skagenslapper frozen rolls (10 pieces/750g; Best before 01/10/2019, 02/10/2019) due to foreign matter (blue plastic pieces) contamination.

Food Safety Recall (Denmark): Dagrofa ApS recalls Gestus Pasta with hot-smoked salmon (360g; All dates from 15.11.2018 to 28.11.2018) due to Listeria contamination.

Food Safety Recall (France): Bergams recalls Bergams brand Purée de carotte, boeuf, épices cajun, patate douce (Best before 13/10 to 06/11, inclusive) due to Listeria monocytogenes contamination.

Food Safety Recall (France): Bergams recalls Bergams brand Wrap chaud, bœuf, légumes à l’orientale (Best before 12/10 to 05/11, inclusive) due to Listeria monocytogenes contamination.

Food Safety Recall (France): Intermarché recalls Maredoc brand clams (1kg and 3kg; Sold November 6 – 12, 2018) due to Salmonella contamination.

Food Safety Recall (Germany): Ferme Chapuis recalls Perle de Compostelle raw milk cheese (Best before 16.11.2018; Product of France) due to verotoxin-producing E. coli.

Food Safety Recall (Ireland): Caffreys recalls Confectionery Halloween Bloodie Mallows (All batches; Best before 30 January 2019) due to possible Salmonella contamination.

Food Safety Recall (Ireland): Aldi recalls The Deli Green Pesto (140g; Use by 23.11.2018) due to Salmonella contamination.

Food Safety Recall (Ireland): Goldsmith Goats recalls Goldsmith Goats Raw Goats Milk (All batch codes; All use-by dates) due to contamination with Escherichia coli O157 vt1.

Food Safety Recall (UK-England): Booths recalls Booths mince pies (4-pack; Batch code P/463246; Best before 12 January 2019) due to foreign matter (pieces of white plastic) contamination.

Food Safety Recall (UK-Northern Ireland): Caffreys recalls Confectionery Halloween Bloodie Mallows (All batches; Best before 30 January 2019) due to possible Salmonella contamination.

Pet Food Safety Recall (UK-England): The Raw Factory Ltd recalls various raw pet food products containing tripe and/or pork due to Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Asia, Africa and the Pacific Islands

Food Safety Recall (Hong Kong): Angliss Hong Kong Food Service Ltd recalls Casa Modena brand Mortadella Bologna IGP con pistacchio (Use by November 28, 2018; Product of Italy) due to possible Listeria monocytogenes contamination.

Australia and New Zealand

Food Safety Recall (Australia): My Queen Pty Ltd recalls Mini Cici Jelly and Mini Cici Jelly with dairy (360g; All Best before dates; Product of China) due to a choking hazard.