Recalls and Alerts: February 19 – 21, 2022

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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 UPDATE: FDA continues its follow-up investigation of the Cronobacter sakazakii and Salmonella Newport illnesses linked to powdered infant formula products manufactured by Abbott Nutrition in Sturgis, Michigan.

Canada

Food Safety Recall: Le Valet Épices (Montréal, QC) recalls LE VALET MARINADE (500 ml; Sold up to 18 February 2022) because the product may not be safe to consume.

Europe

Allergy Alert (Sweden): Axfood recalls Smått & gott Godismix Favoriter / Candy Mix Favorites containing “Snickers” packaging (700g) due to undeclared peanuts.

Powdered Infant Formula Safety Recall (Ireland): Abbott recalls Elecare Similac and Alimentum Similac powdered infant formulas (400g; Multiple batch codes and Best-before dates; Product of USA) due to potential for Salmonella and Cronobacter sakazakii contamination. Please refer to the recall notice for a complete list of affected products.

Powdered Infant Formula Safety Recall (UK): Abbott recalls Elecare Similac and Alimentum Similac powdered infant formulas (400g; Multiple batch codes and Best-before dates; Product of USA) due to potential for Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Austria): Baron International D.O.O. recalls BILLA BIO FRUIT BITES HIMBEERE-KAKAO / FRUIT BITES RASPBERRY-COCOA (100g) due to possible foreign matter (plastic parts) contamination.

Food Safety Recall (France): PRODUITS DE LA CIGOGNE recalls PRODUITS DE LA CIGOGNE brand Magret de canard fumé entier / Whole smoked breast of duck (Lot 301604; Use by 29/04/ 2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): Auchan recalls Auchan – Les Bouchées Jambon Fumé Ail et Fines Herbes / Garlic and fine herbs bite-sized smoked ham (100g; Lot 229; Use by 24/03/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): CARREFOUR-MARKET ESSARS recalls crème de foie / creamy liver (Sold by the slice between 8 February 2022 and 9 February 2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): ETS VAISSAIRE PAPON recalls L’ARVERNE brand SAINT NECTAIRE FERMIER cheese (Lot 63VBM040122; Best before 24/ 03/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Luxembourg): LT Foods recalls Golden Sun Riz Basmati / Basmati rice (1 kg; Use by 06/10/2023) due to aflatoxin contamination.

Food Safety Recall (Sweden): Siljans Chark recalls Bacon (Best before 2022-03-04) due to possible Listeria monocytogenes contamination.

Food Safety Recall (UK): Freshers Foods Ltd. recalls various pork snack products due to Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Asia, Africa and the Pacific Islands

Powdered Infant Formula Safety Recall (Israel): Abbott recalls Alimentum and Human Milk Fortifier powdered infant formula products (Expiration date 1.09.2023) due to potential contamination with Cronobacter and/or Salmonella Newport.

Powdered Infant Formula Safety Recall (Singapore): Abbott Laboratories (S) Pte Ltd recalls Abbott Alimentum powdered infant formulas (400g; The first two digits of the code are “22” through “37” and the code on the container contains “K8”, “SH” or “Z2”; Expiration date 1 Apr 2022 or later; Product of USA) due to potential contamination with Cronobacter and/or Salmonella Newport.

Australia and New Zealand

Powdered Infant Formula Safety Recall (Australia): Abbott Australasia Pty Ltd and Abbott US recall some EleCare, Similac and Alimentum infant formula products due to potential contamination with Cronobacter and/or Salmonella. Please refer to the recall notice for a complete list of affected products.

Powdered Infant Formula Safety Recall (New Zealand): Abbott Laboratories NZ Ltd recalls specific batches of its Similac, Alimentum and EleCare brands of infant formula products due to potential contamination with Cronobacter and/or Salmonella Newport. Please refer to the recall notice for a complete list of affected products.

Cronobacter and Powdered Infant Formula

Where we are and how we got here

The current situation

On February 17, 2022, the US Food and Drug administration (FDA) advised the public that it was working with the US Centers for Disease Control and Prevention (CDC) and state and local agencies to investigate four consumer complaints of illnesses in infants.

The infants were fed powdered infant formulas manufactured by Abbott Nutrition in Sturgis, Michigan.

Three of the illnesses were due to Cronobacter sakazakii and the fourth was caused by Salmonella Newport.

The FDA received the illness reports between September 6, 2021, and December 18, 2021, from Minnesota (1), Ohio (1) and Texas (2).

All four of the infected infants were hospitalized. One of the Cronobacter-infected babies died, although it is uncertain whether the infant’s death was solely attributable to the infection.

As a result of the illness reports, the FDA initiated an inspection of the Sturgis production facility. In the course of their investigation, inspectors noted several unspecified adverse inspectional observations. In addition, several positive Cronobacter results were reported from environmental samples taken by FDA.

In response to the FDA’s findings, Abbott Nutrition has initiated a recall of multiple powdered infant formula products sold under the Similac, Alimentum and EleCare brand names. The affected products were manufactured in the Sturgis plant.

The products under recall have a multidigit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after.

This image shows where to find important lot code information on the container.

The recalled products were distributed across the United States and may also have been exported to multiple countries around the world, including: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.

The recall notices

To access detailed information on the recalled products in your country, please click on the appropriate links. For countries not listed below, navigate to Abbott’s website to access additional information.

Cronobacter’s long shadow

Cronobacter was suspected to be a cause of meningitis in infants as long ago as the early 1960s.

In 1981, researchers at the Indiana University School of Medicine were able to confirm the link between Cronobacter sakazakii and a case of fatal meningitis.

In 1983, Dutch researchers were the first to suggest the connection between infant formula and Cronobacter infections. Their hypothesis was proven to be correct in a 1989 report of an Icelandic outbreak of meningitis in three newborn infants.

In 2001, the death of an eleven-day old infant in a neonatal intensive care unit (NICU) of a Tennessee hospital was traced to the use of Portagen powdered infant formula manufactured by Mead Johnson. Cronobacter was recovered from nine of forty-eight infants in the NICU.

The following year, a five-day old Belgian baby died shortly after being released from the hospital. The infant, who was infected with Cronobacter, had been fed Beba powdered formula manufactured by Nestlé.

These incidents prompted the FDA to increase its surveillance of infant formula manufacturers, with special emphasis on the possibility Cronobacter in powdered infant formulas. The agency updated its Compliance Guidance for infant formulas in 2018.

Abbott’s inspection history

Abbott’s infant formula production facility in Sturgis, Michigan, has undergone twenty-seven FDA inspections since October 2008, according to the FDA’s inspection database.

Twenty-four of the twenty-seven inspections resulted in the company’s operations receiving a clean bill of health.

In October 2010, the FDA inspector cited the company for three issues, specifically:

  • Effective measures are not being taken to exclude pests from the processing areas
  • There is no assurance that raw materials which are susceptible to contamination with extraneous materials comply with current FDA standards and defect action levels
  • Failure to manufacture foods under conditions and controls necessary to minimize contamination.

These issues were apparently corrected, as subsequent inspections that same year and for several years did not result in any adverse reports.

The situation changed in September 2019, when the FDA inspector cited Abbott for a single issue, stating:

  • You did not test a representative sample of a production aggregate of a powdered infant formula at the final product stage and before distribution to ensure that the production aggregate meets the required microbiological quality standards.

Once again, the company corrected its procedures to the FDA’s satisfaction.

There were no inspections carried out for two full years. Then, in September 2021, the FDA returned. This time, the inspection uncovered several issues:

  • Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wash hands thoroughly in a handwashing facility at a suitable temperature after the hands may have become soiled or contaminated.
  • You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition
  • An instrument you used to measure, regulate, or control a processing parameter was not properly maintained.
  • You did not monitor the temperature in a thermal processing equipment at a frequency as is necessary to maintain temperature control.
  • You did not install a filter capable of retaining particles 0.5 micrometer or smaller when compressed gas is used at a product filling machine.

In its recall notice, Abbott acknowledged having found “evidence of Cronobacter sakazakii in the plant in non-product contact areas,” but denied having found the bacterium in finished product.

This would appear to be in direct contradiction to the FDA’s revelation that the company had recorded the destruction of product in the past due to the presence of Cronobacter.

FDA advice to consumers

If you want to check if your powdered formula is part of the recall, you can enter the product lot code on the bottom of your package on the company’s website.

If you have questions or need information about the recall, you can Submit Questions/Get Assistance from the FDA.

If your infant is experiencing symptoms related to Cronobacter or Salmonella infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care.

To report an illness or adverse event, you can

Note: Information on the history of Cronobacter infections in infants was drawn from TAINTED: From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures.

For additional information on Cronobacter, visit the CDC web page, Cronobacter infection and infants.

URGENT PUBLIC HEALTH WARNING

Powdered infant formula made by Abbott Nutrition linked to Cronobacter and Salmonella illnesses.

The US Food and Drug Administration (FDA) is investigating four consumer complaints of infant illnesses linked to products from Abbott Nutrition’s Sturgis, MI facility.

The complaints span a period of time from September 6, 2021 to December 18, 2021, and were reported from Minnesota (1), Ohio (1) and Texas (2).

All four infants were fed powdered infant formula produced in Abbott’s Sturgis facility.

The complaints include three reports of Cronobacter illness and one report of Salmonella Newport illness in infants.

All four infants were hospitalized, and one of the infected infants has died.

The death may not be solely attributable to the Cronobacter infection.

The FDA has been conducting an inspection of the facility and has found Cronobacter in several environmental samples. In addition, the company’s internal records include findings of environmental contamination with Cronobacter.

Company records also document the destruction of finished product due to Cronobacter contamination.

The FDA is advising consumers not to use Similac, Alimentum or EleCare powdered infant formulas if:

  • the first two digits of the code are 22 through 37 and
  • the code on the container contains K8, SH, or Z2, and
  • the expiration date is 4-1-2022 (APR 2022) or later.

At this time, the FDA’s advisory is limited to these specific products.

Abbott Nutrition is working with the FDA to initiate a voluntary recall of these products.

Affected products were distributed across the United States and also were likely exported to other countries.

How serious is Cronobacter?

Cronobacter is a foodborne bacterium that can cause a rare, but serious illness in infants. Newborn infants are especially susceptible.

In 2001, nine infants in the Neonatal Intensive Care Unit of a Tennessee hospital were infected with Cronobacter as a result of being tube-fed a batch of Portagen powdered infant formula manufactured by Mead Johnson. One of the babies died.

According to the FDA’s advisory, Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

If your child is experiencing any of these symptoms, you should notify your child’s healthcare provider and seek medical care for your child immediately. Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to CDC.

Additional information about Cronobacter can be found on the CDC’s website. A history of Cronobacter infections (including the 2001 outbreak linked to Portagen infant formula) can be found in Chapter One of TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures.