Recalls and Alerts: October 13-14, 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

Public Health Alert: USDA/FSIS issues consumer alert for FRANK’S BUTCHER SHOP GROUND BEEF (1-lb. plastic vacuum-packed packages; Packed on dates 10-07-2022 and 10-09-2022) due to possible E. coli O103 contamination. The products are no longer available for purchase, but consumers may still have the product stored in their freezer.

Infant Formula Safety Recall: Abbott recalls Ready-to-Feed liquid products for infants and children, including the brands Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution (2 fl oz/59 ml bottles; multiple lot codes) because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. The recalled products were manufactured in Columbus, Ohio and were distributed primarily to hospitals and to some doctors’ offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. Please refer to the Abbott recall website for additional information about the affected products.

Food Safety Recall: Nestlé USA recalls NESTLÉ^® TOLL HOUSE^® STUFFED Chocolate Chip Cookie Dough with Fudge Filling products (8 oz; produced between June and September 2022) due to potential foreign matter contamination (white plastic pieces). The recalled products were distributed in the continental United States and Puerto Rico.

Canada

Infant Formula Safety Recall: Abbott recalls Ready-to-Feed liquid products for infants and children, including the brands Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution (2 fl oz/59 ml bottles; multiple lot codes) because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. The recalled products were manufactured in Columbus, Ohio and were distributed primarily to hospitals and to some doctors’ offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. Please refer to the Abbott recall website for additional information about the affected products.

Food Safety Recall: Abbott recalls Abbott brand Similac Sterilized Water (48 x 59 ml; Lot 39398N200; Expiry 01-OCT-2023) due to spoilage. The recalled product was sold nationally.

Food Safety Recall: Aristo Cuisine recalls multiple Circle K / Couche Tard brand sandwiches (Best before 22-OC-12, 22-OC-13 & 22-OC-14) due to Listeria monocytogenes contamination. Please refer to the recall notice for a complete list of affected products, which were sold in Quebec and may have been distributed in other provinces and territories.

Europe

OUTBREAK INVESTIGATION UPDATE (Sweden): The Swedish Food Agency and the Public Health Agency are continuing to investigate an outbreak of Salmonella Typhimurium that has now sickened 54 people from 20 different regions in the country since September 17, 2022. The source of this outbreak has not yet been identified, but is suspected to be a food with wide distribution in Sweden.

Allergy Alert (Belgium): Albert Heijn recalls AH Koolhydraat verlaagd bollen volkoren / Low-carb whole wheat buns (4 x 60g; Best before 14/10/2022) due to undeclared sesame.

Allergy Alert (Denmark): Candynavia A/S recalls Slikposer – SSC Børnepose / Candy bags – SSC Children’s bag (Best before 31.07.2023) due to undeclared milk.

Allergy Alert (Ireland): FSAI alerts consumers to presence of undeclared sesame seeds in Heera Rewdi (Sugar & Sesame Sweet) (300g; Batch 2G1201221; Best before May 2024)

Allergy Alert (Netherlands): Albert Heijn recalls AH Koolhydraat verlaagd bollen volkoren / Low-carb whole wheat buns (4 x 60g; Best before 14/10/2022) due to undeclared sesame.

Allergy Alert (Spain): PepsiCo España recalls Lay’s Horno al punto de Sal / Lay’s Oven Baked crisps, salted (150g; Batches BV 51501 256, BV 51504 256 and BV 51501 257; Best before 02/04/2023; Product of Belgium) due to undeclared milk, soy and wheat.

Food Safety Recall (Belgium): Borges Agricultural & Industrial Nuts S.A. recalls Sol&Mar brand Almendras fritas con miel y sal – AMANDES frites au miel et au sel / Fried almonds with honey and salt (150g; Lots 1114186, 1114543 & 1114673; Use by 05/04/2023, 19/05/2023 & 01/06/2023, respectively) due to possible foreign matter contamination (metal particles).

Food Safety Recall (Belgium): Delhaize recalls Delhaize brand amandes décortiquées Bio / Organic shelled almonds (250g; Best before 17/02/2023) due to excessive hydrocyanic acid.

Food Safety Recall (Denmark): REMA Distribution A/S recalls several batches of kidney beans in brine, kidney beans in chilli sauce, and white beans in tomato sauce, as small perforations in the cans may lead to microbial contamination, resulting in fermentation. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Finland): Lidl Suomi recalls Sol & Mar paahdetut ja hunajalla ja suolalla kuorrutetut mantelit / Sol & Mar almonds roasted and glazed with honey and salt (150g; Best before 2.5.2023 and 3.5.2023) due to possible foreign matter contamination (metal).

Food Safety Recall (France): ETABLISSEMENTS MASSARDIER SALAISONS MASSARDIER recalls Salaisons Massardier brand tête roulée pistachée / Rolled pork with pistachios (Various package formats; Lots 22620004, 2262005, 22620024, 22620023; Use by 19/10/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): ROLAND MONTERRAT recalls various varieties of Pâtés en croûte / Pàtés in pastry crust (Sold by the slice; Use by dates between 29/10/2022 and 12/11/2022) due to possible Listeria monocytogenes contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (France): AUCHAN RETAIL SERVICES recalls AUCHAN PATE EN CROUTE RICHELIEU / Pàté in pastry crust (2 slices (190g); Lots 227201, 227301, 227701 & 227801; Use by 03/11/2022, 04/11/2022, 08/11/2022 & 09/11/2022, respectively) due to Listeria monocytogenes contamination.

Food Safety Recall (France): ROUFFIAC DISTRIBUTION LECLERC recalls Jambon d’AUCH AC SUPERIEUR cuit / Superior cooked ham (Sold by the slice from 09/09/2022 to 23/09/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): LE FROMAGER DES HALLES recalls LA PERELLE brand Petit Pont l’eveque cheese (240g; Lot 120922LI8; Use by 26/11/2022) due to E. coli contamination.

Food Safety Recall (France): MARIUS BERNARD recalls Les pêcheurs des Calanques brand Aïoli BIO / Organic Aïoli (90g; Lot 1209F1189; Best before 12/09/2024) due to suspected microbial growth.

Food Safety Recall (France): ETABLISSEMENTS FASSIER SA recalls FASSIER brand JAMBONNEAU SUPERIEUR CUIT AU BOUILLON / Superior ham cooked in broth (Lot 2490503000092; Use by 11/10/2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): SCAMARK E.LECLERC recalls COTE TABLE brand SPAGHETTI BOLOGNAISE (415g can; Lot LU097; Best before 30/04/2026) due to possible can perforations that could result in microbial contamination.

Food Safety Recall (France): AUCHAN RETAIL SERVICES recalls AUCHAN brand PERSIL FLOCONS / Parsley flakes (10g; Lot LF2243CA; Best before 31/10/2024) due to possible foreign matter contamination (glass particles).

Food Safety Recall (Germany): Borges Agricultural & Industrial Nuts, S.A. recalls Sol&Mar Frittierte Mandelhälften mit Zucker, Honig und Salz / Fried almonds with sugar, honey and salt (150g; Lot 1114724; Best before 20.06.2023) due to possible foreign matter contamination (metal).

Food Safety Recall (Italy): Gelmini Carlo SRL recalls Pascoli Italiani brand Gorgonzola Dolce DOP / Sweet gorgonzola cheese (300g; Lot 21846252; Best before 08.11.2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Italy): Alicos SRL recalls Alicos brand Pesto al finocchietto selvatico / Wild fennel pesto (190g; Lot 15ST22; Use by 15 September 2024) due to risk of Clostridium botulinum contamination.

Food Safety Recall (Italy): SUPERMERCATI IPERAL S.p.A recalls PORCHETTA D’ARICCIA IGP / Pork roast (90g; Lots V232134, V232703, V233395, V234224, V234230, V235970 & V236047; Use by 30/10/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Luxembourg): Delhaize recalls Delhaize brand amandes décortiquées Bio / Organic shelled almonds (250g; Best before 17/02/2023) due to excessive hydrocyanic acid.

Food Safety Recall (Luxembourg): Salaisons MEYER recalls Meyer brand Pâté au poivre / Pepper pâté (250g; Lot 80-20220913-25; All Use by dates from 15/10/2022 to 22/10/2022) and Meyer brand Pâté au poivre en bloc / Pepper pâté block (Variable weights; Lot 80-20220913-22; All Use by dates from 15/10/2022 to 22/10/2022) due to foreign matter contamination (pieces of rigid black plastic).

Food Safety Recall (Luxembourg): AUCHAN recalls AUCHAN PATE EN CROUTE RICHELIEU / Pàté in pastry crust (2 slices (190g); Lots 227201, 227301, 227701 & 227801; Use by 03/11/2022, 04/11/2022, 08/11/2022 & 09/11/2022, respectively) due to Listeria monocytogenes contamination.

Food Safety Recall (Luxembourg): Food safety authority recalls Boni brand Purée de pommes de terre surgelée / Frozen potato purée (1 kg; Lot BL221757; Best before 23/06/2024) and Boni brand Purée de pommes de terre aux épinards surgelée / Potato and spinach purée, frozen (1 kg; Lot L222107; Best before 28/07/2024) due to foreign matter contamination (glass).

Food Safety Recall (Luxembourg): Borges Agricultural & Industrial Nuts, S.A. recalls Sol & Mar brand Amandes au sucre, miel et sel / Almonds with sugar, honey and salt (150g; Lots 1114186, 1114543 & 1114673; Best before 05/04/2023, 19/05/2023 & 01/06/2023, respectively) due to possible foreign matter contamination (metal).

Food Safety Recall (Netherlands): Layenberger Nutrition Group GmbH recalls multiple varieties of Layenberger Fit+Feelgood Slim Shakes (396g; multiple lot codes and expiration dates) due to possible foreign matter contamination (metal particles).

Food Safety Recall (Netherlands): Hoogvliet recalls Casa del Sud ravioli Bolognese (400g can; Expiration date 30-09-2026) due to possible damaged containers that may develop microbial spoilage.

Food Safety Recall (Netherlands): Lidl recalls Kania erwtensoep / Pea soup (800ml; Expiration date 09-2025) due to possible foreign matter contamination (stones).

Food Safety Recall (Netherlands): Jumbo recalls Ferrero Kinder Schokobons / Chocolate candies (300g; Best before 05-10-2022) due to possible Salmonella contamination. This product was recalled by Ferrero in April; however some of the product was shipped by Jumbo to a limited number of stores in error.

Asia, Africa and the Pacific Islands

Allergy Alert (Israel): Stone Mill Industries Ltd recalls multiple snack products due to undeclared milk. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Singapore): Importers recall Fresh shell eggs (Farm code CEJ027; All batches; Product of Malaysia) due to Salmonella Enteritidis contamination. The farm is also suspended and will not be allowed to export their eggs to Singapore until the contamination problem has been rectified.

Australia and New Zealand

Food Safety Recall (Australia): Murray River Smokehouse recalls Murray River Smokehouse salami mild (180g; Best before 25FEB2023) and Murray River Smokehouse salami pepper (180g; Best before 06MAR2023) due to Salmonella contamination.

Latin America and the Caribbean

Infant Formula Safety Recall: Abbott recalls Ready-to-Feed liquid products for infants and children, including the brands Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution (2 fl oz/59 ml bottles; multiple lot codes) because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. The recalled products were manufactured in Columbus, Ohio and were distributed primarily to hospitals and to some doctors’ offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. Please refer to the Abbott recall website for additional information about the affected products.

Abbott’s senior vice president grilled by members of House subcommittee

This story by Coral Beach first appeared at Food Safety News and is reposted here with permission

“We know we let you down.”

The senior vice president of Abbott Nutrition — the manufacturer of infant formula whose plant closure amid a food safety investigation has left the country in dire straits with parents scrambling to find food for their babies — opened his testimony before a U.S. House panel Wednesday with that admission of guilt.

The day-long hearing before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce was billed as an investigation into the infant formula shortage and the reasons behind it.

During the first half of the hearing members of the U.S. House of Representatives grilled top administrators from the Food and Drug Administration about the shortage and the agency’s investigation into Abbott’s Sturgis, MI, manufacturing plant. FDA Commissioner Robert Califf told the panel that the agency could have done a better job managing its investigation. (See our related story for complete coverage.)

The second half of the day was reserved for three executives from the baby food industry with about half of the time devoted to the shortage and the other half focusing solely on Abbott’s food safety status.

Abbott was represented by its senior vice president Christopher Calamari. Two other infant formula manufacturers also had top executives on hand to answer questions: Scott Fitz, vice president of Gerber, and Robert Cleveland, senior vice president of Reckitt. Together the three companies represent about 90 percent of the infant formula market in the United States. Abbott alone has 40 percent of the market.

Members of the House subcommittee questioned all three men about the status of infant formula production with little in the way of solutions offered for resolving the current shortage. All of the companies are working to meet the need with ramped-up production at U.S. plants. They are also working with the federal government to increase imports of infant formula.

As pressing as the need for more infant formula is, the reason behind the shortage received as much time in the spotlight as the shortage itself. If Abbott had not had to close down its Sturgis, MI, plant because of food safety issues there would not be a shortage.

Calamari repeatedly told the House subcommittee that Abbott is doing everything possible to get its plant up and running. It was closed down in mid-February when the company initiated a massive recall. The recall came amid an FDA investigation into links to a cronobacter outbreak that saw at least four babies hospitalized. Two of them died.

Time after time Calamari said that Abbott is “taking steps” to resolve food safety problems and make sure they don’t reoccur. Time after time the House members asked what the company is doing.

When Committee Chair Rep. Diana DeGette, D-CO, asked the question Calamari gave his generalized answer. DeGettee called him on it, seeking more specifics. The Abbott senior vice president then ticked off a handful of actions including replacing floors, repairing the roof, and changing the way personnel move through the 700,000-square-foot manufacturing plant.

During her closing remarks, the subcommittee chair remarked on the bipartisan outrage about the situation at the Abbott plant. She told Calamari that his answers had been “too vague.”

Highlights from other subcommittee members’ questions about the food safety situation and the answers from Calamari follow.

Rep. H. Morgan Griffith, R-VA
The ranking member of the subcommittee told Calamari that Abbott has more than a problem with its roof and floors. He cited a whistleblower document that reported managers hiding information from top corporate management and said the company has a “culture problem” and asked, “have any heads rolled?”

Calamari responded by saying he didn’t think it was a culture problem and that just last week he visited the Sturgis, MI, plant and met with multiple generations of employees there who are committed to producing safe infant formula.

Rep. Cathy McMorris Rodgers, R-WA
When the representative asked why there were cronobacter bacteria in the production facility Calamari said “it wasn’t in the production area,” adding that it is a naturally occurring bacteria. McMorris Rodgers asked Calamari what Abbott is doing to make sure its food safety issues do not recur he said the company “is committed to preventing future problems.”

Rep. Michael C. Burgess, R-TX
Burgess wanted to know when Abbott management was made aware of the whistleblower document. Calamari said they didn’t know about it until it was made public by Congress in April. He also said he did not want to speak to points made in the document because it is the subject of an ongoing investigation.

Rep. Kathleen M. Rice, D-NY
Rice also asked Calamari about the whistleblower document, wanting to know what measures Abbott has in place for employees to raise food safety concerns. Calamari said there is an “independent” entity within the company that takes and reviews employee concerns and that it was the whistleblower’s choice to not use the system to report concerns. Rice also asked what the company plans to do to make sure employees feel comfortable reporting issues and Calamari said the company would “encourage them to speak up.”

Rep. Janice D. Schakowsky, D-IL
Telling Calamari that she is “livid” about the situation and that the inspection report about the Sturgis, MI, plant is “disgusting,” Schakowsky asked him if he would take personal responsibility; he said “yes.”

Rep. Gary J. Palmer, R-AL
Calamari told Palmer that he was not aware of problems at the plant until FDA inspected it earlier this year. When Palmer asked why problems had not been addressed earlier Calamari said the company is committed to safety.

Rep. Scott H. Peters, D-CA
Peters asked how much of Abbott’s resources go toward food safety and Calamari said “tens of millions of dollars.” Peters then asked if it should be more. Calamari said, “we are committed to doing what it takes.”

Rep. Kim Schrier, D-WA
Schrier wanted to know why Congress should trust Abbott to fix problems at the production plant, especially in light of the whistleblower accusations of falsified records. Calamari said, “we are aligned with the FDA” on plans to reopen the plant.

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’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.”