Recalls and Alerts: July 28-29, 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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Chapter 6. Birth of a Pathogen

United States

OUTBREAK INVESTIGATION UPDATE: FDA continues to investigate consumer complaints of gastrointestinal illness and abnormal liver function that may be attributable to eating Daily Harvest French Lentil & Leek Crumbles frozen product. FDA has received 329 reports of illness, including 113 hospitalizations.

Allergy Alert: Wilbur’s of Maine Chocolate Confections recalls Milk Chocolate Blueberries (8-oz pouch; Expiry date April 5, 2023; UPC 81321300430) due to undeclared almonds.

Food Safety Recall: Danny’s Sub and Pizza (dba Danny’s Cuban Pizza) recalls approximately 19,275 pounds of frozen meat pizza products that were produced without the benefit of federal inspection. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Lyons Magnus LLC recalls 53 nutritional and beverage products due to the potential for microbial contamination, including from the organism Cronobacter sakazakii. Preliminary root cause analysis shows that the products did not meet commercial sterility specifications. Please refer to the recall notice for a complete list of affected products.

Canada

Allergy Alert: Daniel Chocolates and Groove Chocolate Inc. recall certain dark chocolate bars due to undeclared milk. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Boulangerie-Pâtisserie Casablanca inc. (Montréal, QC) recalls pastries and bakery products sold up to 27 July 2022 due to a food safety hazard. Consumers who purchased products from this location should either discard them or return them to the store.

Europe

Allergy Alert (Belgium): De Zaligheden recalls Chipolata de campagne / Country sausage (500g; Use by 31-07-2022, 03-08-2022 & 04-08-2022) due to undeclared eggs.

Allergy Alert (Belgium): Flavori international recalls Flavori brand épices couscous 7 légumes / 7-vegetable couscous spices (100g; Lot M09102004; Best before 25/11/2024) due to undeclared wheat (gluten).

Allergy Alert (Finland): Mums Oy recalls Fallero Roasted beetroot and Fallero Pea – Kale (210g; Products dated 31.7., 2.8., 7.8. and 9.8. 2022) due to undeclared gluten.

Allergy Alert (France): BJORG ET COMPAGNIE recalls Bjorg brand Muesli superfruits (375g; Lot A1 05/05 8:30 to A1 05/05 16:00; Best before 03/09/ 2023) due to undeclared soy and hazelnuts.

Allergy Alert (Germany): Niococktails srl recalls Nio Cocktails – Mai Tai (100 ml; Product of Italy) due to undeclared almonds.

Allergy Alert (Italy): Eskigel s.r.l. recalls Decò brand 6 Lemon Stecchi con bastoncino alla liquirizia / 6 Lemon sticks with licorice (480g (6 x 80g); Lots LTE 2186, LTE 2192, LTE 2193, LTE 2200 & LTE 2201; Best before 05/2024) due to undeclared gluten.

Allergy Alert (Italy): Niococktails srl recalls Nio Cocktails – Mai Tai (100 ml; Product of Italy) due to undeclared almonds.

Allergy Alert (Luxembourg): De Zaligheden recalls Chipolata de campagne / Country sausage (500g; Use by 31-07-2022, 03-08-2022 & 04-08-2022) due to undeclared eggs.

Food Safety Recall (Belgium): Delhaize recalls Delhaize brand ROTI FILET DINDE FICELE / Roasted turkey tenderloin (Use by 07-08-2022) due to Salmonella contamination.

Food Safety Recall (France): FRUITS ROUGES & CO recalls FRUITS ROUGES & Co. brand Framboises surgelées / Frozen raspberries (500g; Lot 34073001; Best before 18/11/2023) due to Norovirus contamination.

Food Safety Recall (France): FROMAGERIE LA CAPRARIUS recalls LA CAPRARIUS brand TOMME DE BREBIS AU FENUGREC / Sheep’s milk cheese with fenugreek (Lot 20 2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): SUD VENDEE DISTRIBUTION LECLERC recalls ELPOZO brand Longanisse douce / Sweet Spanish pork sausage (Lot 09RR080000021372; Use by 15/08/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): LE FROMAGER DES HALLES recalls Tomme fraîche fermière / Fresh farm cheese (Lot 1607; Use by 09/08/2022) due to possible shigatoxin-producing E. coli contamination.

Food Safety Recall (France): ARRIVE SAS recalls MAÎTRE COQ brand Nuggets de Poulet / Chicken nuggets (1 kg; Lot 2P22201; Use by 12/08/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Germany): DöllingHareico Fleisch- und Wurstwaren GmbH & Co. KG recalls ja! Delikatess Cervelatwurst / Cervelat sausage slices (200g; Best before 15.08.2022) due to foreign matter contamination (part of conveyor belt).

Food Safety Recall (Luxembourg): Cactus recalls three Cactus brand burgers due to E. coli O157 contamination. Please refer to the recall notice for a complete list of affected products.

Asia, Africa and the Pacific Islands

Allergy Alert (Hong Kong): PARKnSHOP (HK) Limited recalls CASINO brand Hazelnut Filled Biscuit (125g; Best before April 18, 2023; Product of France) due to undeclared peanuts.

Australia and New Zealand

Food Safety Recall (New Zealand): Middle East Ltd recalls Algota brand Sesame Tahini (all packaging size variations; Batches 498 & 359; Product of Syria) due to possible Salmonella contamination.

Nine baby deaths reported to FDA during Abbott Nutrition investigation

Between December 1, 2021, and March 3, 2022, the US Food and Drug Administration (FDA) received nine (9) reports of infant deaths among babies who were fed powdered infant formula manufactured by Abbott Nutrition in Sturgis, Michigan.

The infant death reports were included in a list of 128 consumer complaints supplied to eFoodAlert by the FDA in response to a Freedom of Information Act (FOIA) request. (see: Abbott Nutrition consumer complaints file, Redacted)

Two of the deaths were numbered among the four confirmed outbreak cases of Cronobacter sakazakii identified by the US Centers for Disease Control and Prevention (CDC).

The other seven deaths were reported to the FDA via the agency’s consumer complaint system. Two of those reports mentioned Salmonella in the complaint description.

In addition to the nine deaths, consumers described twenty-five (25) incidents categorized as “Life Threatening Illness/Injury” and eighty (80) instances of “Non-Life Threatening Illness/Injury.”

Fourteen consumers contacted the FDA to obtain information or clarifications on the Abbott recall.

The complaints were lodged with FDA District Offices across the continental USA.

Salmonella was present in two of the dead babies, and was mentioned in seventeen other illness complaints.

One of the surviving infants was infected with both Salmonella and E. coli.

The symptoms suffered by the infants were mostly consistent with a gastrointestinal infection: fever (31 babies), vomiting (42 babies), diarrhea (47 babies), and blood in stool (6). Most babies suffered from multiple symptoms.

Other reported symptoms included loss of appetite, rash (either localized or spread over entire body), lethargy, dehydration, irritability, weight loss, and difficulty breathing.

Some of the infants suffered from multiple infections:

The FDA did not respond to eFoodAlert‘s request for comment on what was done to follow up on the seven infant death reports that did not involve Cronobacter sakazakii, or on the non-fatal illnesses not involving Cronobacter.

According to an agency spokesperson, the FDA, along with the CDC and state and local partners, investigated consumer complaints and/or reports, received from September 20, 2021 to February 24, 2022, of infant illness.

The spokesperson did not address any of the more than thirty complaints–including three reported deaths–received by FDA district offices between February 25, 2022 and March 3, 2022.

Two of those three reported deaths referred to Salmonella.

The FDA investigation uncovered multiple instances of Cronobacter sakazakii in the environment of Abbott’s manufacturing facility.

None of the cultures retrieved from environmental samples were a genetic match for the strain that infected the two babies for which the CDC received cultures. The CDC did not receive cultures from the other two infected babies for genetic analysis.

Although there is no direct evidence in the form of genome sequencing to link any of the illnesses unequivocally to Abbott’s infant formulas, all of the complaints have one element in common.

Every one of the sick babies was fed an Abbott powdered formula.

The FDA has established an Incident Management Group (IMG) under Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

The IMG is tasked with managing the ongoing investigation and monitoring the infant formula supply chain, and will remain in place at least until the current supply shortage is over, according to the FDA spokesperson.

In Memoriam

With production now having resumed–under close supervision–at the Abbott Nutrition plant in Sturgis, the time has come to acknowledge the lives that were lost.

We know very little about the nine infants who died. For privacy reasons, their names, ages, genders, where they lived, and when they died have been withheld. They are identified only by their unique Complaint ID numbers.

  • Complaint ID #171222, reported December 1, 2021. Infant arrived to the ER in cardiac arrest. Cronobacter sakazakii and Proteus mirabilis. Infant had consumed Similac Pro-Total Comfort (Powder) infant formula, Lot #23495K80.
  • Complaint ID #172435, reported February 22, 2022. Vomiting, swollen organs, trouble breathing. Infant had consumed Similac Advance, Lot #34875K80.
  • Complaint ID #172477, reported February 22, 2022. Screaming. Infant had consumed Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, et al, infant formula powder, Lot #34869K80.
  • Complaint ID #172479, reported February 23, 2022. Fever, diarrhea, loss of appetite, vomiting. Infant had consumed Similac Advanced infant formula. Lot number not available.
  • Complaint ID #172541, reported February 24, 2022. Tested positive for Cronobacter sakazakii. Infant had consumed Similac PM 60/40, Lot #27032K800.
  • Complaint ID #172585, reported February 24, 2022. No details available. Infant had consumed EleCare infant formula, Lot number not available.
  • Complaint ID #172607, reported February 28, 2022. Cause of death and opinion pending further studies (Congenital). Infant had consumed Similac Elecare powdered infant formula, Lot #34771Z21 1306305
  • Complaint ID #172632, reported March 2, 2022. Salmonella meningitis, ventriculitis, vomit, diarrhea, seizures, bradycardia. Infant had consumed Similac Pro Advance infant formula, Lot #25598SHO 0557 015 SIMESPWD.
  • Complaint ID #172636, reported March 2, 2022. Salmonella. Infant had consumed Similac Total Comfort, Lot #26834K80.

May they rest in peace.

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.

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