Recalls and Alerts: May 12-13, 2022

TAINTED formats 3

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.

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations? Click on the TAINTED menu at the top of the page to read or listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Listen to an excerpt of the new audiobook edition right here

Chapter 6. Birth of a Pathogen

United States

OUTBREAK INVESTIGATION: The CDC has closed its investigation into an outbreak of four cases of Cronobacter sakazakii infections in infants. All four infants were hospitalized, and two of them died. The FDA investigation into the incident, which is linked to consumption of powdered infant formulas manufactured by Abbott Nutrition in Sturgis, Michigan, is on-going.

Allergy Alert: HP Hood LLC recalls Planet Oat Chocolate Peanut Butter Swirl Non-Dairy Frozen Dessert ( 1 pt – 473 ml; Best before 12/17/22; UPC 44100709869) and Planet Oat Chocolate Chip Cookie Dough Non-Dairy Frozen Dessert (1 pt – 473 ml; Best before 12/17/22; UPC 44100709906) due to undeclared peanuts.

Allergy Alert: USDA/FSIS issues public health alert due to concerns that Weis Markets’ ready-to-eat (RTE) General Tso Chicken meals may contain milk. Please refer to the public health alert for a complete list of affected products. The products are no longer available for sale.

Allergy Alert: Mrs Miller’s Homemade Jams recalls Smokey BBQ Bacon Jam and Spicy Chili Bacon Jam (packed in glass jars; Sold 04/01/2019 – 05/09/2022) due to undeclared soy.

Food Safety Recall: Mars Wrigley Confectionery US, LLC recalls specific varieties of SKITTLES® Gummies, STARBURST® Gummies, and LIFE SAVERS® Gummies due to potential foreign matter contamination (very thin metal strand). Please refer to the recall notice for a complete list of affected products.

Food Safety Alert: New York State warns consumers not to consume unpasteurized raw milk from Thomas Miller DBA Miller Dairy Farm due to possible Listeria monocytogenes contamination.

Canada

Allergy Alert: Tree Brewing Co. recalls Tree Brewing Co. brand Golden Larch Grapefruit Radler (473 ml; Packaged 16MAR2022; UPC 6 24524 21543 8) and Tree Brewing Co. brand Season Pass 8-pack (8 x 473 ml; Packaged 15MAR2022; UPC 6 24524 45498 1) due to undeclared sulphites.

Food Safety Recall: Au Quai (Drummondville, QC) recalls HARENG FUMÉ À L’HUILE / Smoked herring in oil (Sold up to 10 May 2022) due to improper packaging that presents a food safety hazard.

Food Safety Recall: Gourmet Laurier inc. (Montréal, QC) recalls multiple cheeses made with raw milk due to the absence of a “raw milk” warning on the labels.

Food Safety Recall: Petits pots et gourmandises (Le Locker Distillerie inc., Sainte-Anne-de-Beaupré, QC) recalls three products packed in glass jars (750 ml; Sold up to 12 May 2022) due to improper packaging that presents a food safety hazard.

Food Safety Recall: Mars Wrigley Canada recalls specific varieties of SKITTLES® Gummies, STARBURST® Gummies and LIFE SAVERS® Gummies due to the potential presence of a very thin metal strand embedded in the gummies or loose in the bag. Please refer to the recall notice for a complete list of affected products.

Europe

OUTBREAK INVESTIGATION UPDATE (Belgium): AFSCA reports 62 cases of Salmonella infections linked to consumption of Kinder chocolate products manufactured by Ferrero in Arlon, Belgium. These cases are part of a multinational outbreak.

Allergy Alert (Belgium): AFSCA recalls Chongqing brand Instant Noodle – Hot & Sour Flavour (110g; All lot codes and Best before dates) due to undeclared milk.

Allergy Alert (Belgium): AFSCA recalls ALL4TRADE – ZINE brand Bulgur grof bruin / Coarse brown bulgur (800g; Best before 10/2022) due to undeclared wheat.

Allergy Alert (Ireland): FSAI warns consumers of undeclared wheat in ALL4TRADE – ZINE brand Coarse brown bulgur (800g; Best before 10/2022)

Allergy Alert (Luxembourg): Food Safety Authority recalls Chongqing brand Instant Noodle – Hot & Sour Flavour (110g; All lot codes and Best before dates) due to undeclared milk.

Allergy Alert (Spain): AESAN recalls ALL4TRADE – ZINE brand Bulgur grof bruin / Coarse brown bulgur (800g; Best before 10/2022) due to undeclared wheat.

Food Safety Recall (Belgium): Belki NV recalls Carrefour (Belki) brand burger de poulet Halal et burger de poulet nature / Halal chicken burger and plain chicken burger (250g; Lots 220505012 & 220502020; Use by 15/5/2022 & 13/5/2022, respectively) due to possible Salmonella contamination.

Food Safety Recall (Belgium): Carrefour recalls Carrefour brand Fromage d’Abbaye / cheese (230g; All Best before dates between 12/05/2022 and 14/05/2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France):  L’Aquarium recalls Huitres No. 2 / Oysters (Lot 050522H) due to E. coli contamination.

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

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

Food Safety Recall (France): LIDL recalls Baguette Céréales Rustique (250g; All lot codes) due to foreign matter contamination (metal).

Food Safety Recall (France): SCAMARK E.LECLERC recalls NOS REGIONS ONT DU TALENT brand FILETS DE HARENG DOUX DU NORD / Smoked sweet herring fillets (200g; Lot 119; Use by 03/06/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): CASINO recalls Franprix brand Duo de billes de chèvre Paprika coeur à la tomate et Graines de pavot coeur à la tapenade / Goat cheese ball stuffed with paprika and tomato and goat cheese ball stuffed with poppy seed tapinade (2-pack / 65g; Lots S22-104 & S22-115; Use by 19/05/2022 & 30/05/2022, respectively) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): VIABAT recalls VIABAT brand Salade de Pieds de Bovins Emincés / Sliced beef-food salad (Lot 117; Use by dates between 07/06/2022 and 17/06/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): GERMLINE recalls GERMLINE brand Déli’mix sprouts (50g; Lot 220509; Use by 21/05/2022) due to Salmonella contamination.

Food Safety Recall (France): E.LECLERC recalls PECHE OCEAN brand MIETTES DE SURIMI – SAVEUR CRABE / Crab-flavour surimi crumbs (180g; Use by 20/06/2022; Hour stamp between 15:00 and 17:00) due to Listeria monocytogenes contamination.

Food Safety Recall (France): E.LECLERC recalls LES CROISES brand DUO DE BILLES CHÈVRE TOMATE/PAPRIKA – TAPENADE/PAVOT / Pair of stuffed goat cheese balls – Tomato/paprika and Poppy seed/tapenade (65g; Use by 18/05/2022, 30/05/2022, 06/06/2022 & 07/06/2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): BESNI FOOD recalls Kerem mini figues séchées / Mini dried figs (250g; Lot 21003123 & 22000191; Use by 29/11/2022 & 31/01/2023, respectively) due to aflatoxin contamination.

Food Safety Recall (Germany): Fleisch- und Wurstwaren Schmalkalden GmbH recalls Wilhelm Brandenburg, Paprikapastete mit Joghurt / Paprika pie with yoghurt (100g; Lot 260422; Best before 17.05.2022) due to foreign matter contamination (metal).

Food Safety Recall (Germany): Villani S.p.A. recalls Salame Cacciatore italiano DOP / Italian salami (150g; Lot 240222; Best before 15.07.2022) due to possible Salmonella and Listeria monocytogenes contamination.

Food Safety Recall (Ireland): Marks & Spencer recalls certain products containing chicken due to possible Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (UK): Cranswick Country Foods recalls multiple cooked chicken products due to potential Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Australia and New Zealand

Allergy Alert (New Zealand): Golden Coin Ltd recalls The Grid brand Shanghai Style Pan-fried Buns (all batches and dates) due to undeclared soy.

Abbott, Ferrero & Strauss – Oh, My!

Analysis and Op-Ed

Although the names sound as though they belong on the letterhead of a law practice, or of an accounting firm, Abbott Nutrition, Ferrero International, and Strauss Group are three distinct companies, located in North America, Europe, and the Middle East, respectively.

Each of these companies is currently managing multinational product recalls.

And two of the recalls have been associated with outbreaks of foodborne disease.

Strauss – Elite Chocolate

On April 19, 2022, Strauss notified Israel’s Ministry of Health that routine testing had revealed the presence of Salmonella “in the manufacturing area” of the company’s Nof HaGlil’ production facility.

The factory manufactures a range of Elite brand chocolate products, and also supplies chocolate to other food processors.

The Ministry of Health instructed Strauss to conduct more extensive tests on its finished products, raw materials, and production environment.

On April 21, 2022, using a rapid test, Strauss found indications of Salmonella in some raw material.

It took an additional three days to confirm these preliminary positive results, during which time no warning was issued to the public. Nor, as far as we can tell, was any product put on hold.

On April 24, 2022, once the preliminary results had been confirmed, Strauss initiated a recall of multiple Elite chocolate products, explaining that Salmonella had been discovered in the production line at the company’s Nof HaGlil’ manufacturing plant. Samples of chocolate used as an ingredient for other products also tested positive for Salmonella.

On April 25, 2022, Unilever Israel recalled multiple ice cream products that contained chocolate supplied by Strauss.

On April 27, 2022, more than one full week after first reporting the presence of Salmonella in the production plant, Strauss expanded its recall to include all expiration dates of all products manufactured by Elite’s chocolate factory, including Elite cakes, Elite wafers, cereal energy bars, chocolate-coated energy rice crisps, bubble gums and taffy candies.

The company has suspended operations at the manufacturing facility while it conducts and investigation into the cause and source of the contamination and carries out an intensive cleaning and sanitizing of the production area.

In addition to being sold throughout Israel, products manufactured in the Nof HaGlil’ facility were exported to multiple countries, including Australia, Austria, Canada, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Romania, Spain, United Kingdom and United States.

Although Israel’s Ministry of Health has not announced any indications of an outbreak linked to the recalled chocolates, The Jerusalem Post reported that a 10-year-old boy was diagnosed with Salmonella on April 27th after being admitted to hospital with severe dehydration as a result of extensive vomiting and diarrhea.

Ferrero – Kinder chocolate products

On December 15, 2021, Ferrero detected Salmonella on the surface and in residual raw materials samples taken from buttermilk tanks in its Arlon, Belgium manufacturing facility.

The company did not notify the Belgian food safety authority of this finding until early April 2022.

Instead, Ferrero suspended production, destroyed the affected semi-finished product, carried out a deep cleaning of the entire line, and resumed production. Finished product manufactured on the line was released for distribution following negative test results.

Additional samples tested in January 2022 also were positive for Salmonella, including two samples from two buttermilk tanks, recorded on January 11th.

As before, the company suspended production, deep-cleaned the line and gradually resumed production.

On February 17, 2022, the UK reported a cluster of monophasic Salmonella Typhimurium cases to the European Centre for Disease Control (ECDC).

Between January 5th and February 8th, Ferrero had submitted nine Salmonella cultures to an Italian lab for serological and molecular typing.

Four of those cultures were a match for the outbreak strain.

By April 8, 2022, the ECDC had received reports of 150 cases from nine EU countries and the UK.

Most of the cases were in children less than ten years of age, and many of the children were hospitalized.

On April 8th, the Belgian food safety authority withdrew its production authorization for Ferrero’s Arlon manufacturing facility, announcing that it could not rely on the information the company had been providing.

That same day, Ferrero recalled all of the Kinder chocolate products manufactured in the Arlon facility.

As of April 19th, the number of cases had risen to 187 cases in 11 EU countries and the UK.

On April 22, 2022, the company expanded its recall to include additional products.

Abbott Nutrition – Powdered infant formula

It could be argued that Strauss’s delay in recalling its chocolate products was relatively minor and without any significant impact on public health.

It is more difficult to justify a similar argument in the case of Ferrero.

Had the company destroyed the finished products impacted by its buttermilk contamination rather than testing and releasing, a multi-national Salmonella outbreak most likely would have been avoided.

Yet, Ferrero’s actions pale in comparison to the situation at Abbott Nutriton’s Sturgis, Michigan production facility, as alleged in a whistleblower complaint lodged with the FDA last October.

According to the whistleblower, company management has been falsifying records, shortchanging preventative maintenance, skimping on sanitation, and turning a blind eye to microbiological problems in the plant.

While we have only the whisteblower’s word for many of the allegations, some of what he or she has reported has been substantiated in the FDA’s Establishment Inspection Reports from September 2019 and September 2021, and in the Inspectional Observations (FDA Form 483) documented during the January – March 2022 investigation of the Sturgis facility, as described in earlier eFoodAlert posts.

FDA actions vis-a-vis Abbott Nutrition

The apparent ease with which Abbott allegedly pulled the wool over the eyes of FDA inspectors during the 2019 and 2021 inspections is troubling, to say the least.

Even though the inspectors were advised during the September 2021 plant visit of consumer complaints of Salmonella infections associated with Abbott products, they did not carry out any independent environmental sampling during the course of their plant visits. Instead, they relied on the company’s reports of how the complaints were investigated and deemed to be unsubstantiated.

Reports of equipment maintenance also were taken at face value, as were sanitation records.

Coincidentally, while the FDA inspectors were on site at Abbott in September 2021, the agency was alerted to the first of four confirmed reports of Cronobacter sakazakii in an infant who had been fed an Abbott powdered infant formula.

The following month, on October 20, 2021, the whistleblower complaint was submitted to the FDA.

The agency did not get around to interviewing the whistleblower until late December, and the FDA did not begin its in-depth investigation into the operations of Abbott’s Sturgis facility until January 31, 2022.

By then, two additional reports of Cronobacter-infected infants and one report of a Salmonella-infected infant had been lodged with the FDA.

Before the completion of the January – March 2022 Abbott inspection, a fourth Cronobacter-infected infant was identified.

TWO OF THE FOUR CRONOBACTER-INFECTED INFANTS DIED.

What next for food safety?

Had Ferrero been living up to its responsibility to produce safe food, there would have been no outbreak of Salmonella Typhimurium in Europe and the UK.

Had Abbott been living up to its responsibility, the four infants would not have become infected with Cronobacter, and the parents of the two dead babies would have been spared a lifetime of grieving.

Likewise, had the FDA lived up to its responsibilities, Abbott’s behavior might have come to light at least two years ago, and the company would have been brought to heel.

There is no excuse for Ferrero, for Abbott Nutrition, or for the FDA.

It is time for food companies who flout good manufacturing practices and who put consumers at risk to pay for their malfeasance.

And it is past time for the US Congress to take a good, long, hard look at the way in which food safety is overseen in the United States.


Learn more about Salmonella in chocolate and Cronobacter sakazakii in infant formula 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 Nutrition: The Gathering Storm

Between September 1, 2019 and September 20, 2021, Abbott Nutrition received seventeen consumer complaints regarding multiple Similac powdered formula products.

Fifteen of the complaints related to infants testing positive for Salmonella after consuming a Similac product. One complaint cited an infant who was diagnozed with Cronobacter (Enterobacter) sakazakii, and one was as the result of an infant death from an unspecified cause.

This information is contained in the September 20-24, 2021, Establishment Inspection Report (EIR), obtained by eFoodAlert from the US Food and Drug Administration (FDA) in response to a Freedom of Information Act request.

How the complaints were handled

In response to the Cronobacter complaint, the company reviewed its batch records and its finished product microbiological testing records. The complaint was reviewed by an internal Abbott Nutrition Medical Team.

The firm closed the complaint after determining that all batch records were acceptable, that there were no other consumer complaints, and that microbiological testing was negative for C. sakazakii.

The infant death complaint triggered a batch record review for three lots of Similac Alimentum. After completing the review and determining that no other complaints or medical concerns had been identified for the products, the company closed the complaint.

The fifteen Salmonella complaints involved infants who had been fed one or more batches of Similac Alimentum, Similac ProAdvance, Similac Spit-Up, Similac Total Comfort, Similac Advance, Similac Pro Sensitive or Elecare for Infants.

All fifteen of the infants tested positive for Salmonella.

Once again, the batch record reviews came back acceptable, and finished product testing results were negative for Salmonella.

A finished product sample of one of the implicated batches (Similac Advance lot #472005) was obtained by Abbott Nutrition from the consumer. The sample was subjected to a visual exam, and the container was examined in the packaging lab.

The company did not conduct any microbiological tests on this sample.

Abbott Nutrition’s ‘Standard Operating Procedure for Handling Complaints’ specifies that “…any chemical or microbial testing of an unopened customer sample requires the approval of the AN Vice President Quality or delegate.”

The EIR does not state whether approval was sought to carry out microbiological tests on the sample.

Abbott’s internal test results raise concerns

In addition to the consumer complaints, the EIR also reveals that the company had found Cronobacter in two batches of finished product.

The first of these positive results was recorded for Similac Alimentum (Batch 697464), produced on September 25, 2019, just one day after the completion of the FDA’s September 2019 inspection of Abbott’s production facility.

The root cause of the contamination was determined to be environmental. The company implemented correction actions and destroyed the contaminated batch.

The specific root cause for the second positive result, this time in Similac Spit-Up (Batch 732675), produced on June 22, 2020, was never found, according to the EIR. Several deficiencies were noted during the root cause investigation, corrective actions were implemented, and the batch was destroyed.

In addition to the two instances of Cronobacter in finished products, Abbott also found Cronobacter in five environmental samples between January 2019 and August 2021. There were no Salmonella-positive environmental samples.

All of the Cronobacter-positive results were from non-product contact surfaces.

In its February 17, 2022 recall notice, Abbott acknowledged “…evidence of Cronobacter sakazakii in the plant in non-product contact areas.”

Yet the FDA investigation recovered Cronobacter sakazakii from at least one swab of what appears to be a contact surface, as described in the 1/31/2022-3/18/2022 Inspectional Observations report (FDA Form 483).

The explanation for the absence of Cronobacter-positive findings on product contact surfaces is revealed in the description of Abbott Nutrition’s environmental sampling procedures as reported in the September 2021 EIR.

According to the description of Abbott Nutrition’s environmental sampling program, the company conducts environmental sampling of product contact surfaces and non-product contact surfaces, as well as air, water, steam and compressed air.

Swab samples from product contact surfaces and non-product contact surfaces are tested for Enterobacteriaceae.

Enterobacteriaceae is a family of bacteria that includes both Salmonella and Cronobacter, and a test for total Enterobacteriaceae may be used as an indicator of general sanitary conditions in a production facility.

If a non-product contact surface produced a positive result in an area of the plant that was considered “high care” by the company, the isolates were analyzed for both Salmonella and Cronobacter.

On the other hand, if a product contact surface was positive for Enterobacteriaceae, the company did NOT test the isolates for Salmonella or Cronobacter, rationalizing that the finished product is analyzed for both microbes.

However, except in the event of massive contamination, Salmonella or Cronobacter most likely would be present at very low levels in the finished product, and the chances of detecting these contaminants would be akin to having the same number come up twice in a row on a roulette wheel.

By choosing not to test Enterobacteriaceae-positive product contact surfaces for Cronobacter or Salmonella, the company missed an opportunity to head off a serious problem.

FDA not blameless

There was a two year gap between inspections of Abbott Nutrition’s production plant in Sturgis, Michigan.

During this time, the United States–indeed, the entire world–was reeling from the Covid-19 pandemic.

When the FDA returned to Abbott, the company’s Covid-19 protection program required that the agency give advance notice of their planned inspection–something that had not been the case in the past.

Although the company had four days notice during which they could “tidy up” in anticipation of the FDA visit, the inspection team still found several issues of note, which were detailed in the Inspectional Observations form (FDA Form 483) provided to the company at the end of the inspection.

But one key observation was missing from the list.

There was no mention of the two finished product batches that had tested positive for Cronobacter sakazakii since the previous inspection, nor of the Cronobacter-positive environmental test results.

These observations were included instead on the Form 483 issued at the end of the January-March 2022 inspection.

According to the September 2021 EIR, the two-person FDA inspection team did not carry out any environmental sampling during the course of their visit, even after learning of the Cronobacter-positive results. Two finished product batches were sampled for nutrient analysis and two for microbiological analysis.

Unanswered questions

Seven months after FDA received the first report of an infant infected with Cronobacter and nearly four months after the agency initiated its in-depth inspection of Abbott Nutrition’s production facility, several questions remain:

  • In view of what the FDA learned in September 2021 regarding Cronobacter-positive environmental and finished product samples at the Abbott facility, why did it take more than four months for the agency to initiate another inspection after receiving the first of the illness reports?
  • Why did the FDA inspectors not respond more forcefully to those Cronobacter-positive results when writing up the list of Inspectional Observations at the completion of their September 2021 inspection?
  • Would Abbott have discovered and addressed its contamination problem sooner if it had tested product-contact surfaces for Cronobacter instead of relying upon finished product tests?
  • As Cronobacter (unlike Salmonella) is not a “reportable” disease in most states, how many additional cases of Cronobacter in infants have gone unreported?
  • Why did it take until February 17, 2022, before the public was made aware of the situation?

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