Recalls and Alerts: May 14-18, 2022

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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Chapter 6. Birth of a Pathogen

United States

Allergy Alert: Dierbergs Markets recalls Fresh Garden Spiral Pasta Salad (12 oz & 2 lb family pack; Sell by 5/31/22) due to undeclared egg.

Food Safety Recall: America New York Ri Wang Food Group Co., Ltd. recalls approximately 14,635 pounds of ready-to-eat (RTE) sausage sticks and luncheon loaf products due to possible foreign matter contamination (metal). Please refer to the recall notice for a complete list of affected products.

Public Health Alert: USDA/FSIS issues Public Health Alert for Great Value Black Forest Ham Water Added (1 lb resealable pkg; Best if used by 07/15/22) because the product may be underprocessed. A recall was not requested because it is believed that the product is no longer available for consumers to purchase.

Canada

Allergy Alert: Royal Import & Export Ltd. recalls Jumbo brand Melk Chocopasta (Milk Chocolate Spread) (400g; Lot 17921B; Best before 08/2022; UPC 8 718452 449873) due to undeclared hazelnuts.

Allergy Alert: GB Foods recalls various GB Foods brand sausage products due to undeclared gluten and/or wheat. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Le Centre d’action bénévole aux 4 vents (Waterloo, QC) recalls Saumon fumé / Smoked salmon (Sold up to 17 May 2022) due to lack of storage temperature specification on product label.

Food Safety Recall: Le Caveau FRUITS ET LÉGUMES (Sainte-Agathe-des-Monts, QC) recalls MAQUEREAU FUMÉ / Smoked mackerel (Sold up to 17 May 2022) due to lack of storage temperature specification on product label.

Food Safety Recall: Canadian Choice Wholesalers recalls Suzie’s brand Organic Cocktail Sauce (237 ml; Best by 10/07/22; UPC 0 47281 20142 9) due to spoilage.

Food Safety Recall: Mantab Inc. recalls Below Zero brand Whole Raspberries IQF (1 kg; Lot XT21253; Best before 2023-SE-09; UPC 0 69821 06020 4) due to Norovirus contamination.

Europe

OUTBREAK INVESTIGATION UPDATE (Multiple countries): ECDC reports 324 cases (266 confirmed and 58 probable) of monophasic Salmonella Typhimurium infections in twelve EU countries and the UK have now been associated with consumption of Kinder – Ferrero chocolate products manufactured in Arlon, Belgium. Cases have also been identified in Canada (1 case), Switzerland (43 cases) and the United States (1 case), bringing the total to 369 cases.

Allergy Alert (Belgium): Traindevie recalls multiple products due to undeclared milk. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (France): Monoprix recalls Monoprix brand La Baguette Jambon Emmental / Ham and Emmental cheese baguette (Use by dates between 16/05/2022 and 21/05/2022 due to undeclared sesame.

Allergy Alert (Iceland): Kjöt & Pylsumeistarinn recalls Steikarpylsa / Steak sausage (400-480g pkgs and in bulk; All best before dates up to 18.05.2022) due to undeclared mustard.

Allergy Alert (Ireland): Industry recalls Just Free Gluten Free Black Pudding (260g; Batch 041-22; Use by 20/05/2022) and Just Free Gluten Free White Pudding (260g; Batch 041-22; Use by 20/05/2022) due to undeclared gluten.

Allergy Alert (Luxembourg): Food Safety Authority recalls several Vó Elisa brand products due to undeclared sesame. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (Spain): Mulitple brands of chocolate products contain undeclared peanuts. Please see AESAN notice for a complete list of affected products.

Allergy Alert (UK): Asian Traders Ltd recalls Parle Premium Rusk (200g; Batch code PA ATL/3694; Best before 04 June 2022) due to undeclared milk.

Allergy Alert (UK): SP Wholesale recalls Wonka Bar (Milk Chocolate) (100g; Batch codes 18121P & 33421P; Best before 30 June 2023 & 30 November 2023, respectively) due to undeclared almonds and peanuts.

Allergy Alert (UK – Northern Ireland): Lidl NI recalls Just Free Gluten Free Black Pudding (260g; Batch 041-22; Use by 20/05/2022) and Just Free Gluten Free White Pudding (260g; Batch 041-22; Use by 20/05/2022) due to undeclared gluten.

Allergy Alert Update (UK): Lidl GB recalls Starovice Czech Lager 5.0% (500 ml; All Best Before dates up to and including 23 December 2022) due to undeclared sulphur dioxide.

Food Safety Recall (Belgium): Detry sa recalls AUBEL brand Boulettes Rôties / Roasted meatballs (6+1 / 595g; Lot 7732; Use by 11/06/2022) due to defective package seals.

Food Safety Recall (France): PERIGORD FARINES MINOTERIE ALLAFORT recalls FARINE DE BLE NOIR SARRASIN FLUIDE / Buckwheat flour (1 kg; Lot 118CS11; Best before 29/10/2022) due to Salmonella contamination.

Food Safety Recall (France): Auchan recalls ESCALOPES DE POULET / Chicken breasts (Sold between 11 and 16 April) due to Salmonella contamination.

Food Safety Recall (France): SCEA DU CERISIER EARL du Cerisier recalls SCEA du Cerisier brand pâté croute moutarde ancienne / Old-fashioned mustard pâté with crust (Use by 01/06/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): AUCHAN RETAIL SERVICES AUCHAN NANCY TOMBLAINE recalls POITRINE DE PORC MARINEE TEX-MEX / marinated pork breast meat (Sold between 3 and 17 May 2022) due to Salmonella contamination.

Food Safety Recall (France): AUCHAN RETAIL SERVICES AUCHAN SUPERMARCHE VOUVRAY recalls JAMBON TRADITIONNEL PERE CHAMPAIN / Traditional ham (Sold from 05/05/2022 to 17/ 05/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): Salaisons Michel Loge recalls saucisson sec / Dry sausage (Lot SA220701) due to Salmonella contamination.

Food Safety Recall (France): DISTRIBUTION CASINO FRANCE CASINO – Produits Frais Traditionnels recalls Salade de Pieds de Bovins Emincés / Sliced cow’s food salad (Sold from 27/04/2022 to 09/05/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): JIRD INTERMARCHE recalls SIEBERT brand CUISSE DE POULET / Chicken leg (Lot 3160422922; Use by 27/04/2022) due to Salmonella contamination.

Food Safety Recall (France): Lidl recalls Baguette Céréales Rustique / Rustic seeded baguette (Baked on site) due to foreign matter contamination (metal).

Food Safety Recall (France): J.C.David recalls La Cuisine du Poissonnier brand Filets de hareng doux fumé / Mild smoked herring fillets (200g; Lot 119; Use by 03/06/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Germany): Maggi GmbH recalls MAGGI 5 Minuten Terrine Kartoffelbrei mit Steinpilzen / 5-minute mashed potato with porcini mushroom terrine (Lots 21270703Z, 21280703Z, 21290703Z; Best before 31.05.2023) and MAGGI 5 Minuten Terrine Kartoffelbrei mit Röstzwiebeln & Croûtons +25% / 5-minute mashed potato terrine with roasted onions and croutons +25% (Lot 21280703Z; Best before 31.05.2023) due to foreign matter contamination (metal).

Food Safety Recall (Iceland): John Ross Junior ltd recalls John Ross brand Scottish smoked salmon (340g; Best before 28.05.22) due to Listeria monocytogenes contamination.

Food Safety Recall (Ireland): Industry recalls Villani Cacciatore Italiano salami (170g; Batch code 240222; Best before 15.07.22; Product of Italy) due to Salmonella and Listeria monocytogenes contamination.

Food Safety Recall (Italy): Villani SpA recalls Villani salame cacciatore (170g; Lots 240222 & 26/01/22; Best before 15/07/2022) due to Salmonella and Listeria monocytogenes contamination.

Food Safety Recall (Netherlands): DekaMarkt recalls 1 de beste Baguettes wit 2 stuks (two-pack; Best before 14-08-2022) due to possible foreign matter contamination (metal).

Asia, Africa and the Pacific Islands

Food Safety Recall (Israel): Israel Ministry of Health has instructed Tnuva to recall powdered milk manufactured between 9/8 and 25/8/2021 due to possible Salmonella contamination. The milk powder was supplied to food manufacturers and not distributed on the retail market.

Abbott’s walk of shame

As reported yesterday, Abbott Nutrition has entered into a Consent Decree of Permanent Injunction that spells out the conditions under which the company will be permitted to recommence and continue powdered infant formula production at its Sturgis, Michigan, plant.

Despite the company’s protestations of innocence regarding the outbreak of four cases of Cronobacter sakazakii illnesses–including two deaths–in infants who consumed Abbott’s products, the formal Complaint filed by the US Justice Department sets out very clearly the extent of Abbott’s culpability.

The Complaint

After summarizing the relevant statutes, regulations and rules, the Complaint lists the following supporting evidence, found during the inspections carried out by US Food and Drug Administration (FDA) investigators in September 2021 and January-February 2022.

FDA lab analysis found C. sakazakii on several surfaces in the production area, including the cover of a hopper that feeds scoops directly into infant formula containers. The sample was collected at the time a batch of formula was being packaged, and the scoops come into direct contact with product.
Abbott’s own environmental samples confirmed the presence of Cronobacter spp. on surfaces in the powdered infant formula production area between September 25, 2019, and February 20, 2022. The company did not perform the necessary test to determine whether or not the bacteria were Cronobacter sakazakii.
On January 31, 2022, FDA investigators noted the presence of pooled water on several levels of a multi-story spray dryer tower while the spray dryer was being used to produce a batch of powdered infant formula.
Abbott’s own records documented a total of 310 “water events” (leaks and condensation) between January 1, 2020, and February 1, 2022, in dry-production areas for powdered infant formula (e.g. during spray-drying and/or container-filling operations). Several of those leaks are described in the company’s records as necessitating repairs to a roof.
Abbott had never validated the dry-out step for their spray dryers to ensure that the interiors of the dryers are completely dry following cleaning.
Abbott’s own records documented a history of internal deterioration of the spray dryers dating back to September 2018, including (but not limited to) pits and cracks inside the dryers’ main chambers.
Plant personnel working in the infant formula production area did not always wear necessary protective apparel.
The company failed to conduct an adequate investigation into the validity of a complaint that showed a possible health hazard existed, and failed to test any retained samples of the suspect production lot for microbiological contamination.
At the completion of the September 2021 inspection, the FDA issued an FDA-483 form, listing several deficiencies. Although Abbott promised to take corrective action, the company did not implement sustained corrections or demonstrate ongoing compliance with statutory requirements.

On behalf of the FDA, the US Department of Justice has petitioned the Court to issue a permanent injunction requiring Abbott to “… cease manufacturing, processing, preparing, packing, labeling, holding, and/or distributing any article of food unless and until Defendants bring their manufacturing, processing, preparing, packing, labeling, holding, and distribution operations into compliance with the Act and its implementing regulations to the satisfaction of FDA.”

The request also includes authorization for FDA to inspect the company’s “… place(s) of business and all records relating to the receipt, manufacture, processing, preparing, packing, labeling, holding, and distribution of any article of food to ensure continuing compliance with the terms of the injunction, and that Defendants bear the costs of such inspections, including testing and sampling …” and to award costs to the government, including the cost of the investigation to date.

A short leash

The conditions stipulated in the Consent Decree under which Abbott Nutrition will be allowed to resume and maintain production will keep the company on a very short leash.

Abbott will be required to retain an independent expert or experts to evaluate all of the facilities and processes at the Sturgis, Michigan, location, and conduct an inspection to determine what will be necessary to bring the operation into compliance with FDA regulations. The company will be required to notify FDA of the identity and qualifications of the expert within two days after retaining him or her.

Abbott will need to verify the dry-out procedures and validate its method of testing for moisture in production equipment and processing environments.

A pre-production cleaning, sanitizing and dry-out followed by environmental testing for pathogens will be required.

Before starting production, Abbott will be required to provide FDA with a report from the expert that documents completion of all of the verification and validation activities and the pre-production review.

Once production has started, a qualified individual within Abbott’s quality unit will be required to review the batch record, product test results and environmental monitoring for every production lot prior to distribution of the lot. The responsible individual must certify in writing to FDA that each lot meets all specifications.

The consent decree also specifies the testing that must be conducted, and that production be halted and FDA be notified immediately in the event that any in-process or finished product test detects Cronobacter and/or Salmonella. Production will only resume after Abbott receives written permission from FDA.

Abbott must maintain a record of all sales and distribution of its products and make those records available to FDA immediately upon request.

Additional details include specifics as to the required environmental monitoring, training of personnel, preparation and submission to FDA of a plan for building and/or equipment repair, hiring of an auditor to conduct audit inspections of the production facility, methods and processes.

Under the provisions of the decree, in the event the FDA determines that Abbott has not lived up to its agreement, the agency has the authority to order the company to cease manufacturing, and to take whatever other corrective actions the agency deems necessary for protection of public health.

The foregoing is just a sample of the details contained in the 33-page Consent Decree and the 21-page Complaint. Nor is this the end of the story.

In his blog post this morning, Bill Marler warns that criminal sanctions may be in the offing.

Let’s hope the FDA and the US Department of Justice don’t consider Abbott Nutrition to be “too big to nail.”

Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

TAINTED formats 3 — “Reads like a true crime novel” – Food Safety News

Abbott enters consent decree with FDA

Abbott Nutrition and the US Food and Drug Administration (FDA) have entered into a consent decree that will enable powdered infant formula production to restart at the company’s Sturgis, Michigan facility in as little as two weeks.

Once production has recommenced, the company estimates it will take from six to eight weeks for product to reach store shelves.

Operations at the Sturgis facility were halted in February 2022, after four infants became ill with Cronobacter sakazakii infections. The infants were fed four different Abbott products: Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40.

Two of the infants died.

According to a statement released by the FDA, under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law.

The proposed decreee also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected, as well as the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

The proposed consent decree was filed in U.S. District Court for the Western District of Michigan, and is subject to court approval.

“No conclusive evidence”

In its news release, Abbott emphasized that the FDA and CDC investigations found “… no conclusive evidence to link Abbott’s formulas to these infant illnesses.”

The company listed the following findings of the investigations

CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.
Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility.
The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.
Genetic sequencing on the two available samples from ill infants did not match the strains of Cronobactersakazakii found in our plant. Samples from ill infants did not match each other, which means there was no connection between the two cases.
In all four cases, the state, FDA and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

What FDA found

During the intensive investiation carried out by twelve-person team, the FDA documented multiple failings at Abbott’s Sturgis facility.

These included,

Cronobacter sakazakii found in multiple locations in “medium and high care areas of powdered infant formula production, including the hinge attachment and bolt heads on the cover of a scoop hopper for a filler line in the packaging room.
FDA found evidence of Cronobacter sakazakii in a dryer.
Review of company’s records indicated two finished product batches had tested positive for Cronobacter sakazakii.
Water dripping onto the floor in the production area from valves.
Standing water in powdered infant formula production areas (a repeat observation that was first made during the FDA’s September 2021 inspection of the facility and which had not yet been corrected).
Review of company’s records showed a history of internal deterioration in spray dryers dating back to September 2018.
Abbott’s complaint investigations on four consumer complaints (three dealing with Cronobacter sakazakii illnesses and one with a Salmonella Newport illness) did not identify the root causes of the illnesses
During an investigation into the death due to Cronobacter sakazakii of an infant who had been fed Similac Pro Total Comfort infant powder formula, the company’s investigation team did not request that retain samples from the implicated batch of product be tested, even though the company’s own Standard Operating Procedure required this to be done.

During a routine inspection of the Sturgis plant carried out in September 2021, the FDA reviewed complaints received by the company in the two years since its previous inspection. These included:

One complaint of a Cronobacter sakazakii illness in an infant fed Similac Pro-Sensitive powdered formula
One death of an infant fed three different production lots of Similac Alimentum
Fifteen complaints of Salmonella infections in infants fed various Similac or Elecare products. Although an unopened finished product sample was obtained from one of the fifteen cases, no microbiological analysis was conducted on the sample.

All of the complaints were closed by the company following internal investigations.

What next for Abbott?

While there is no smoking gun to conclusively link Abbott’s powdered infant formula products with the four Cronobacter sakazakii illnesses and two deaths, circumstantial evidence is strong, despite the company’s protest to the contrary.

All four victims were fed a product manufactured in Abbott’s Sturgis, Michigan facility
The Sturgis facility had numerous, longstanding maintenance issues, some of which (such as cracks in dryer surfaces) would have increased the risk of chronic pockets of contamination in and on production equipment.
Both the company and the FDA recovered Cronobacter sakazakii from environmental swabs during the 2022 investigation.
Abbott had a history of bacterial illness complaints (15 Salmonella, one Cronobacter sakazakii and one unspecified) during the two years immediately prior to the first reported outbreak case.

At least three separate lawsuits have been filed against the company by parents who believe their babies were made ill as a result of having been fed one of the Abbott powdered infant formula products.

As Rachel Maddow of MSNBC would say, “Watch this space.”