Tag: FDA

Recalls and Alerts: November 9–10, 2023

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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United States

OUTBREAK INVESTIGATION: FDA and CDC are investigating seven cases of Salmonella Kiambu infections linked to contact with dry dog foods manufactured by Mid America Pet Food (see expanded recall notice, below). Six of the seven outbreak victims are children less than one year of age. One person has been hospitalized.

Allergy Alert: Lulu Restaurant Group recalls SISTER SISTER GENERAL TSO’S CHICKEN with FRIED RICE (16-oz plastic trays; Lot codes 11/07/23, 11/11/23, 11/17/23, 11/18/23, or 11/19/23) due to undeclared sesame oil.

Allergy Alert: Frito-Lay recalls Off The Eaten Path Chickpea Veggie Crisps (6 1/4 oz; Batch codes 55432514MH, 55432516MH, and 55432517MH; Use by 12 MAR 2024) due to undeclared milk.

Food Safety Recall: WanaBana USA recalls WanaBana, Schnucks, and Weis brands Apple Cinnamon Fruit Purée pouches (All lots) due to elevated levels of lead. Please refer to the recall notice for additional details on the affected products.

Food Safety Recall: SOFIA PRODUCE, LLC recalls Malichita brand fresh cantaloupes (All sizes; Sold under sales orders between October 16, 2023 and October 23, 2023; PLU code 4050; Product of Mexico) due to Salmonella contamination.

Pet Food Safety Recall: Mid America Pet Food recalls Victor Super Premium Dog Foods, Wayne Feeds Dog Food, Eagle Mountain Pet Food, and some Member’s Mark varieties (Best By Dates before 10/31/24) due to Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

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Canada

Food Safety Recall: Poissonnerie Sami (Montréal, QC) recalls Saumon fumé / Smoked salmon (Sold up to 10 November 2023) due to absence of mandatory “Use by date” labeling.

Food Safety Recall: IGA extra Pointe-Claire (Pointe-Claire, QC) recalls Bœuf haché extra maigre, Bœuf haché mi-maigre, Bœuf haché maigre, & Porc haché / Extra lean, medium lean and lean ground beef, and ground pork (Packaged 9 November 2023; Sold between noon and 15:00 on 9 November 2023) due to foreign matter contamination (pieces of metal).

Food Safety Recall: Boucherie Claude et Henri 2005 inc. (Montréal, QC) recalls Sauce Chien / Chien sauce (All lots) due to absence of mandatory storage temperature labeling.

Food Safety Recall: Ran Foods Inc. recalls HO-YA brand Naturally Brewed Soy Sauce (2 x 900 ml; Lot SP0003; Best before 12. MA. 2025, 06. JN. 2025, 07. JN. 2025, 25. JN. 2025, 26. JN. 2025; UPC 8 83204 00536 7 and 8 83204 00562 6) due to bursting lids.

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Europe

OUTBREAK INVESTIGATION UPDATE (Finland): Investigators have determined that elevated levels of glycoalkaloid in a single batch of potato flakes used as in ingredient in multiple varieties of dry pet food is the most likely cause of numerous complaints of sick pets.

Allergy Alert (Germany): Josef Maier GmbH & Co. KG recalls Wildschweinbratwurst, gebrüht tiefgefroren / Wild boar sausages, scalded and frozen (400g; Multiple lot codes and Best before dates) due to undeclared mustard.

Allergy Alert (Ireland): Tesco recalls Tesco Plant Chef Sweet Potato & Chickpea Tikka Masala (400g; Batch code L23215S; Best before 31 August 2024) due to undeclared milk.

Allergy Alert (Netherlands): Jumbo Supermarkten recalls Jumbo Lekker Vrij van Lactose Magere Yoghurt / Lactose-free, low fat yoghurt (1 L; Best before 13-11-2023) due to undeclared lactose.

Allergy Alert (Spain): Industry recalls Spar, High King, Auchan, Eroski, and Carrefour brands of Garden Soup due to undeclared mustard. Please refer to the recall notice for a complete list of affected lot codes.

Allergy Alert (UK): Tesco recalls Tesco Plant Chef Sweet Potato & Chickpea Tikka Masala (400g; Batch code L23215S; Best before 31 August 2024) due to undeclared milk.

Food Safety Recall (France): LAITERIE DE MONTAIGU – SAS SABOURIN recalls Laiterie de Montaigu brand Crème anglaise (1/2 L; Lot A3319; Best before 12/01/2024) due to an organoleptic defect.

Food Safety Recall (France): Industry recalls Bigi Mama brand Stockfish Cod Heads (10 x 500g; Lot 170823; Best before 01/09/2025) due to foreign matter contamination.

Food Safety Recall (France): LES SALOIRS D’ESPELETTE recalls Kukulu, Ezpela, Tomme d’Espelette, Kalaka brands Fromage brebis poivron piment / Pepper and pimento sheep milk cheese (500-600g; Lot BP52223-600GR; Best before dates between 21/11/2023 and 31/03/2024) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): Lidl recalls Etal du volailler brand Cuisse de dinde / Turkey legs (Lot 0343161473 & 0343161584; Use by 29/10/2023 & 30/10/2023, respectively) due to Listeria monocytogenes contamination.

Food Safety Recall (France): FERME DU TREFLE BLANC recalls all Ferme du Trèfle Blanc brand products packed in glass jars (All lots; All Use by dates between 09/11/2023 and 13/10/2026) due to inadequate sterilization and the risk of Clostridium botulinum.

Food Safety Recall (France): DE ROCHE ROUSSE recalls Ferme de Roche rousse brand Bleu du Vercors Sassenage organic cheese (Lot 2509; Best before 25/11/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (France): CARLAC MARJORIE recalls multiple LES DELICES DE MARJORIE brand products packed in glass jars due to a food safety hazard. Please refer to the recall notice for a list of affected products.

Food Safety Recall (France): NEIGE INTERMARCHE recalls kalaka poivron rouge piment au lait cru de brebis / Pepper-pimento raw sheep milk cheese (Use by 05/11/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (France): ACHATS MARCHANDISES CASINO recalls Casino brand Boules tomate / Tomato balls (42g; Best before 12/04/2024 & 26/04/2024) due to foreign matter contamination.

Food Safety Recall (France): ACHATS MARCHANDISES CASINO recalls Leader Price brand Boules tomate / Tomato balls (50g; Best before 26/04/2024) due to foreign matter contamination.

Food Safety Recall (France): POUNY recalls Onno brand CHORIZO PUR PORC DOUX / Mild pure pork chorizo sausage (Lot 2323300139; Best before 19/11/2023) due to Salmonella contamination.

Food Safety Recall (France): EUROPE SNACKS BIOCOOP recalls BIOCOOP BOULE TOMATE BIO / Organic tomato balls (60g; Lot 291; Best before 19/04/2024) due to possible foreign matter contamination (metal).

Food Safety Recall (France): SNV recalls Le Minaret brand Cuisse de dinde halal / Halal turkey leg (Lot 0343161504 & 0343161739; Use by 29/10/2023 & 30/10/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (France): COOPERATIVE U ENSEIGNE recalls various flavors of U brand snacking balls due to possible foreign matter contamination (metal). Please refer to the recall notice for a list of affected products.

Food Safety Recall (France): SCAMARK E.LECLERC recalls various flavors of Tokapi brand snacking balls due to possible foreign matter contamination (metal). Please refer to the recall notice for a list of affected products.

Food Safety Recall (France): SCAMARK E.LECLERC recalls various flavors of BIO VILLAGE brand snacking balls due to possible foreign matter contamination (metal). Please refer to the recall notice for a list of affected products.

Food Safety Recall (France): SODIROCHE E. LECLERC recalls Salade de pois chiches à la Libanaise / Lebanese style chickpea salad (All lots) due to Listeria monocytogenes contamination.

Food Safety Recall (France): SA MAISON CHAPUIS recalls multiple taboula and rice dishes due to Listeria monocytogenes contamination. Please refer to the recall notices at Rappel Conso for complete information.

Food Safety Recall (France): VERET SAMUEL SARL recalls L’Oie gourmande brand Conserve de cassoulet / Cassoulet (1 kg can; Lot C 06 07 27; Best before 06/07/2027) due to risk of Clostridium botulinum.

Food Safety Recall (Germany): nur puur bio GmbH recalls nur puur Brechbohnen / Beans (340g; Lots LB122222.46000 to LB122222.49000 and LB121230.48000 to LB121230.53000) due to foreign matter contamination (broken glass).

Food Safety Recall (Italy): Alimenta S.p.A. recalls Vale brand Provolone Valpadana DOP dolce / Mild Provolone cheese (250g; Lot 2196987; Best before 23-01-2024) due to Listeria monocytogenes contamination.

Food Safety Recall (Luxembourg): Industry recalls Demeter brand nur puur Brechbohnen / Beans (340g; Lots LB122222.46000 to LB122222.49000 and LB121230.48000 to LB121230.53000; Best before 31/12/2026) due to foreign matter contamination (broken glass).

Food Safety Recall (Sweden): ICA recalls various ICA brand shell eggs (Best before dates up to and including 26-11-2023 with egg code 2SE672-34 or 2SE672-35 printed on the eggs) due to possible Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Sweden): Axfood recalls Garant Ägg, Frigående inomhus, Medium / Free-range eggs, medium size (6-pack and 15-pack; Best before dates up to and including 26-11-2023 with egg code 2SE672-34 or 2SE672-35 printed on the eggs) due to possible Salmonella contamination.

Food Safety Recall (Sweden): Krönagg recalls Kronägg, Ägg från frigående höns inomhus / Free-range eggs (6-pack, 10-pack, 15-pack, 18-pack, 20-pack, 30-pack; Best before dates up to and including 26-11-2023 with egg code 2SE672-34 or 2SE672-35 printed on the eggs) due to possible Salmonella contamination.

Australia and New Zealand

Allergy Alert (Australia): Tassal Operations Pty Ltd recalls tassal Salmon with Coconut Kaffir & Lime Marinade (All Use By dates from 01 DEC 2022 to 08 FEB 2024) due to undeclared milk and soy.

Allergy Alert (Australia): Vegan Delight recalls CIGKOFTE (1 kg & 250g; All best before dates up to and including 01 DEC 2023) due to undeclared walnuts.

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FDA issues new compliance measures for infant formula testing and reporting

This report by Coral Beach first appeared in Food Safety News and is reposted here with permission.

In response to the infant formula supply crisis in 2022 and the deadly infections that led to it, the FDA has updated its infant formula compliance program.

An outbreak of Cronobacter infections in five infants, two of whom died, started in the fall of 2021 and stretched into early 2022. Abbott Nutrition initiated a recall of Similac infant formula powder and other brands in February 2022. The recall led to a nationwide shortage and left parents driving for hours in search of formula for their babies.

During its investigation, the Food and Drug Administration found Cronobacter contamination in Abbott’s production plant in Sturgis, MI. The agency also discovered that the company had tested product and received positive outcomes for Cronobacter, which Abbott had not reported to the FDA.

In May 2022, after grueling congressional hearings, FDA officials launched an internal investigation that included review of issues raised by a whistleblower complaint. The new compliance program is in response to that investigation. The program covers FDA investigators, laboratory analysts, and compliance officers. 

“The infant formula compliance program is designed to comprehensively outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the U.S. food supply are safe and nutritious,” according to a statement from FDA.

“The FDA has now published its updated compliance program, which builds on lessons learned over the last several years to elaborate on our approaches for inspections, sampling, laboratory analysis, and imported infant formula products.”

Going forward, to be in compliance entities must follow updated instructions for annual environmental sampling at powdered infant formula production facilities. Those sampling tests must include Cronobacter and Salmonella. If testing shows either of the pathogens the FDA must be notified. The agency also must be notified if testing shows nutrients that are above or below required levels per the FDA’s infant formula regulation.

The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program at the Food and Drug Administration.

Additional background on the risks associated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program. 

In addition, it further elaborates on new infant formula related requirements that were included in the Food and Drug Omnibus Reform Act of 2022.

All updates related to the FDA’s oversight of infant formula can be found on the FDA’s Infant Formula webpage.

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

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen

TAINTED is available in digital format from all major on-line retailers. Press the button to go directly to your preferred digital bookstore.

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Apple
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Chapters/Indigo

Pre-cooked lobster with a side order of Listeria

Greenhead Lobster Products LLC‘s (Greenhead) ready-to-eat (RTE) seafood processing facility in Bucksport, Maine, suffers from a chronic environmental contamination with Listeria monocytogenes, according to information extracted from US Food and Drug Administration’s website.

The persistent presence of the pathogen in the production environment has been known to the company and the FDA for at least the last two years.

First inspection: 2020

The FDA first visited the Bucksport facility in December 2020, issuing a list of adverse Inspectional Observations (FDA Form 483) upon completion of the inspection.

According to the agency’s inspection citations database, the FDA investigators cited four violations, including:

  • Failure to implement the monitoring procedures listed in the company’s HACCP plan;
  • Failure of the HACCP plan to list the food safety hazards that are reasonably likely to occur;
  • Failure to monitor the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary objects; and
  • A corrective action plan not in accordance with regulatory requirements to ensure that a potentially hazardous product is not entered into commerce.

Second inspection: 2021

After giving Greenhead a grace period of several months to bring its food safety programs into compliance, the FDA performed a follow-up inspection in September-October 2021.

During the 2021 inspection, FDA investigators conducted extensive environmental sampling of the facilities production areas, including food-contact surfaces, and found Listeria monocytogenes in a floor drain.

Upon reviewing the company’s environmental monitoring records, the agency noted the presence of thirteen (13) recurring L. monocytogenes positive swabs between May 2021 and August 2021 from the RTE (ready-to-eat) processing room, including eleven (11) swabs collected from food-contact surfaces.

Although the company’s records indicated that the relevant areas were cleaned and sanitized following each positive finding, Greenhead did not conduct any root cause analysis to establish and eliminate the source or sources of the contamination.

Recall #1

On October 2, 2021, while the FDA inspection was still in progress, Greenhead initiated a voluntary product recall, encompassing 5,749 lbs. of frozen cooked lobster meat. The recall cited a “…potential for contamination … noted after a routine sampling program by the company revealed the presence of Listeria monocytogenes.”

Once again, the FDA issued a Form 483 upon completion of the inspection, this time classifying the situation as “Official Action Indicated.”

Warning Letter

On January 24, 2022, after exchanges of communcations regarding the company’s plans for correcting the various deviations, the FDA issued a formal Warning Letter, giving Greenhead a deadline to respond to all outstanding issues.

The Warning Letter reiterated the list of observations included in the Form 483, providing examples to support each item. These included:

  • Ongoing serious concerns with the company’s HACCP plan
  • Ongoing concerns about the company’s inability to control Listeria monocytogenes in the production environment
  • Significant deviations from requirements of the Seafood HACCP plan
  • Insufficient monitoring of sanitation conditions and practices during processing
  • Inadequate control of the hazard of Clostridium botulinum in high pressure processed (HPP) lobster products.

Third inspection: 2022

In July 2022, the FDA returned to Bucksport yet again to follow up on Greenhead’s response to the Warning Letter.

And yet again, the company’s performance was found wanting.

The Form 483 issued upon completion of the July 2022 inspection listed four main concerns:

  • Greenhead’s HACCP plan did not list the food safety hazards that were reasonably likely to occur
  • The HACCP plan listed a critical limit that failed to ensure control of one or more hazards
  • The company did not take corrective action to prevent potentially hazardous product from entering into commerce, and did not correct the cause of the deviation
  • The company was not monitoring sanitation conditions and practices with sufficient frequency to ensure compliance with current Good Manufacturing Practices.

At the close of inspection, company management agreed to make the necessary corrections and the FDA classified the results of the inspection as “Voluntary Action Indicated.”

Fourth inspection: 2023?

Recall #2

Just over one year later, on October 20, 2023, Greenhead announced another voluntary product recall, this time encompassing “…all frozen and refrigerated cooked lobster meat products produced from May 9, 2023, through October 19, 2023.”

The reason given for the recall was the presence of Listeria monocytogenes in the production environment.

Although the environment was contaminated, the pathogen was not found in finished products, and there were no illnesses associated with the recalled products.

The recall encompassed eleven ready-to-eat, refrigerated or frozen lobster products. Please refer to the recall notice for a detailed list of affected products.

The recall notice made no reference to the FDA. Nor has the FDA posted information on a 2023 inspection in its Inspection Citations database.

Nevertheless, past experience suggests that another follow-up inspection is either still in progress or has been completed recently.

What next for Greenhead Lobster Products?

Although constituted as a regulatory agency, the FDA has a history and a philosophy of giving the food companies it regulates multiple chances to self-correct.

Sometimes, this works well. Other times, it does not.

Greenhead has now been inspected on at least three (and possibly four) separate occasions, and its HACCP and sanitation programs were found wanting each time.

The FDA has the power to demand compliance (via a Warning Letter), to mandate recalls (when circumstances demand), and even to shut down a facility by suspending its registration.

Except for the issuance of a Warning Letter, the agency rarely makes use of these regulatory powers.

Will Greenhead prove to be one of those rare occasions, or will the FDA sit on its hands until one or more illnesses are linked to the company’s products?

Stay tuned.

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

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen

TAINTED is available in digital format from all major on-line retailers. Press the button to go directly to your preferred digital bookstore.

Amazon
Apple
Barnes & Noble
Kobo
Smashwords
Chapters/Indigo