Category Archives: Death

Outbreak Investigation of Listeria monocytogenes: Ice Cream (July 2022)

FDA

The FDA, along with CDC, is assisting the Florida Department of Health (FL DOH) and Florida Department of Agriculture & Consumer Services (FDACS) in investigating an outbreak of Listeria monocytogenes infections linked to ice cream supplied by Big Olaf Creamery of Sarasota, Florida. As of August 2, 2022, CDC reports 25 illnesses in 11 states.

This is an ongoing investigation, and the FDA is continuing to work with the FL DOH and FDACS to investigate. FDA will update this advisory should additional consumer safety information become available.

Recommendation

Consumers, restaurants, and retailers should not eat, sell, or serve any recalled Big Olaf ice cream products and should throw the product away, regardless of the “Best By” or expiration date.

Listeria is most likely to sicken pregnant people and their newborns, adults aged 65 or older, and people with weakened immune systems. Other people can be infected with Listeria, but they rarely become seriously ill.

Call your healthcare provider right away if you have these symptoms after eating Big Olaf ice cream products:

  • Pregnant people typically experience only fever, fatigue, and muscle aches. However, Listeria infection during pregnancy can lead to miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn.
  • People who are not pregnant may experience headache, stiff neck, confusion, loss of balance, and convulsions, in addition to fever and muscle aches.

Consumers, restaurants, and retailers who purchased or received any recalled Big Olaf ice cream products should throw the products away, follow FDA’s safe handling and cleaning advice and use extra vigilance in cleaning and sanitizing any surfaces and containers that may have come in contact with these products to reduce the risk of cross-contamination. Listeria can survive in refrigerated temperatures and can easily spread to other foods and surfaces.

Product Images

Big Olaf Ice Cream Product Image

The Big Olaf brand ice cream was sold to consumers in plastic pint size containers, plastic ½ gallon containers, and plastic 2.5-gallon tubs, scoopable are sold to the independent retail stores. All flavors, lots, codes, and all expiration dates through 6/30/2022 are included in this recall.

Case Count Map Provided by CDC

Outbreak Investigation of Listeria Monocytogenes in Florida-Based Big Olaf Ice Cream (July 2022) - CDC Case Count Map as of August 4, 2022

Map of U.S. Distribution of Recalled Big Olaf’s Ice Cream Products

Outbreak Investigation of Listeria Monocytogenes from Florida-Based Ice Cream - Map of U.S. Distribution of Recalled Ice Cream (July 13, 2022)

Case Counts

Total Illnesses: 25
Hospitalizations: 24
Deaths: 1
Fetal Loss: 1
Last illness onset: 6/24/2022
States with Cases: CO (1), FL (13), GA (1), IL (1), KS (1), NE (1), MA (2), MN (1), NJ (1), NY (2), PA (1)
Product Distribution*: FL, OH
*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states

USA – Listeria Outbreak Connected to Big Olaf Creamery Allegedly Causes Death of One Woman

Food Poisoning News

A recent outbreak of Listeria infections is believed to be linked to an ice cream producer in Sarasota, Florida, called Big Olaf Creamery. The U.S. Center for Disease Control and Prevention (CDC) reports that there have been 23 people affected by the outbreak with 22 of these people seeking hospitalization due to the severity of their symptoms. One woman, Mary Billman, has passed away, allegedly due to the consumption of Big Olaf ice cream. Ms. Billman’s estate is pursuing legal action in response to her death.

Spain – Seven face charges in deadly Listeria outbreak in Spain

Food Safety News

Seven people are set to stand trial as part of Spain’s largest ever Listeria outbreak, which occurred in 2019.

A judge in a court in Seville this week decided to continue proceedings against seven defendants for offences including alleged crimes against public health and injury to a fetus resulting in abortion. At the conclusion of an investigation into the outbreak, Pilar Ordóñez also considered that Seville Council could be held civilly liable, this means it would have to pay compensation if convicted.

The outbreak from “La Mecha” brand chilled roasted pork produced by Magrudis affected almost 250 people. During the health alert between mid-August and mid-October 2019, four people died and there were six abortions.

Those investigated are José Antonio Marín Ponce, administrator of Magrudis; his wife, Encarnación Rodríguez Jiménez, responsible for production and the company’s self-control system; their children Sandro José and Mario Marín Rodríguez as well as a local veterinary inspector and two other people. Action against another four people has been stopped.

Canada – Two dead in Listeria outbreak at Ottawa retirement home

Ottawa Citizen

Two residents of a west-end Ottawa retirement home are dead after a Listeria outbreak, the source of which has not been identified.

Catherine Clausi, a spokesperson for the home on Meadowlands Drive, said it has worked with Ottawa Public Health and the regional infection prevention and control team to determine the source of listeria, but has been unable to do so.

“Despite a month of investigating the outbreak with Ottawa Public Health, no known source was identified,” she said.

She added that the home purchases all of its food “through reliable suppliers and requires staff to follow all food storage and handling procedures.

France – Foodwatch complaint targets Nestlé and Ferrero

LEX

A consumer watchdog has filed a complaint against Nestlé and Ferrero in relation to recent E. coli and Salmonella outbreaks involving the companies.

In the action, Foodwatch France lists seven offences including placing on the market products harmful to health and failure to implement procedures to withdraw or recall such a product, endangering the lives of others and export to a non-EU country of food potentially harmful to health.

The two complaints include the case of Louna, a 6-year-old, who was hospitalized because of a Salmonella infection after eating Kinder chocolate, said Foodwatch. The multi-country outbreak has sickened hundreds.

The Nestlé E. coli outbreak involves 56 cases and two deaths from Buitoni brand Fraîch’Up pizzas in France. Production at the factory in Caudry was stopped in April. The Paris prosecutor’s office has opened a criminal inquiry into the incident.

The Ferrero monophasic Salmonella typhimurium chocolate outbreak has affected at least 324 people in 16 countries. Belgian authorities halted production at the Arlon facility in April, and an investigation has been launched by the Luxembourg Public Prosecutor’s Office.

The two Foodwatch complaints against Nestlé and Ferrero were filed in Paris this week by the law firm Teissonniere Topaloff Lafforgue Andreu et Associés (TTLA) on behalf of the group and several victims. They are seeking sanctions against the companies and compensation for the victims.

India – Food poisoning: E.Coli, Coliforms found in samples from snacks shop

New Indian Express

KASARGOD: The presence of e-Coli and coliform bacteria was found in the food samples taken from Ideal snacks bar at Cheruvathur, said an official source. The Department of Food Safety had sent the samples for testing at the Regional Analytical Laboratory in Kozhikode after a schoolgirl, who had shawarma from the eatery, died, and another 52 persons who ate from there fell sick.

The presence of the highly contagious shigella bacteria, which causes intestinal infection, was found in the blood and stool samples of the patients tested at Kozhikode Medical College Hospital.
The laboratory is now conducting tests on the food samples to ascertain the presence of shigella and salmonella, another bacteria that affect the intestinal tracts, said the source. Only after these two tests, the report would be officially released.

India – Shigella caused food poisoning in girl who died after eating shawarma: Kerala health department

India Express

Shigella - kswfoodworld

Kerala health department on Tuesday identified shigella bacteria as the cause of food poisoning which claimed the life of a student and led to the hospitalisation of around 30 others in the state’s Kasaragod district.

District medical officer Dr S K Ramdas said the presence of shigella was confirmed after testing the blood and faeces of those undergoing treatment for food poisoning. The samples collected from the hospitalised persons were tested at the government medical college hospital in Kozhikode, he said.

Former employee blows whistle on baby formula production plant tied to outbreak – Cronobacter

EFOOD ALERT

A whistle blower document regarding product safety at a plant that manufactured infant formula linked to a deadly, ongoing outbreak provides damning information against Abbott Nutrition, the maker of Similac and other popular formulas that have been recalled in relation to the outbreak.

The document, sent to top officials at the Food and Drug Administration in October 2021, sparked outrage from U.S. Rep. Rosa DeLauro who has already demanded information from the FDA regarding the Cronobacter outbreak among babies. DeLauro, D-CT, on April 28 shared a redacted version of the whistle blower complaint and renewed her criticism of FDA and Abbott Nutrition for their slow response to the outbreak in which at least four babies have been hospitalized, with two having died.

“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the FDA,” DeLauro said during a meeting on the Fiscal Year 2023 Budget Request for the United States Department of Agriculture.

“I am equally concerned that the FDA reacted far too slowly to this report. The report was submitted to the FDA on October 20, 2021. The FDA did not interview the whistleblower until late December 2021. According to news reports, FDA did not inspect the plant in person until January 31, 2022, and the recall was not issued until February 17, 2022.”

Read the full story at the link above.

USA – FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022) – The problem is more than two years old.

FDA

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 websiteExternal Link Disclaimer.

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

If your infant is experiencing symptoms related to Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements; contact your health care provider to report their symptoms and receive immediate care.

To report an illness or adverse event, you can

The FDA, along with CDC and state and local partners are investigating consumer complaints and/or reports of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility. All of the ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI facility.

The FDA is releasing the FDA Form 483s from three inspections conducted at Abbott Nutrition’s facility on Sept. 16-24, 2019Sept. 20-24, 2021, and Jan. 31-March 18, 2022. The inspectional observations in these Form 483s do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. FDA will take appropriate action in the future – if warranted – as we continue to evaluate the 2022 inspectional findings.

Important observations noted in the 2022 Form 483 include, but are not limited to:

  • [Abbott Nutrition] did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.
  • [Abbott Nutrition] did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.

Once the immediate public health risk is minimized, FDA will conduct a programmatic review to ensure the maximum effectiveness of agency programs and policies related to infant formula and special medical food complaints, illnesses, and recalls.

Conducting this review is a top priority for the FDA and will be done as efficiently as possible, and we can ensure this effort will not interfere with the immediate recall response activities. We will and must continue focusing on taking all steps possible to protect the health of those who rely on safe powdered infant formula.

Recommendation

The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package (see image below). Products are included in the recall if they have all three items below:

  • 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.

In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code 27032K80 (can) / 27032K800 (case). At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) is the only type and lot of this specialty formula being recalled. Additional recall information for the initial recall is available on the FDA website. Parents can also enter their product lot code on the company’s websiteExternal Link Disclaimer to check if it is part of the recall.

Additional information for parents and caregivers of infants receiving medical specialty infant formulas and individuals using certain medical foods is available below.

Additional Information for Parents and Caregivers:

The recalls do not include liquid formula products.

Parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants. Consumers should also avoid purchasing imported formula through online sales, as it has the potential to be counterfeit.

If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.

If you get infant formula through WIC, do not throw the formula out. Instead, you should take it to the store for a refund and exchange or call the company at 1-800-986-8540 to help you. WIC recipients should be able to obtain a different brand of similar formula. Call your local WIC clinic for more guidance. Also see:

More information on Cronobacter and infant formula is available on CDC’s website.

Recalled powdered infant formulas have the potential to be contaminated with Cronobacter, a bacterium that can cause severe foodborne illness primarily in infants. Cronobacter infections are rare but are especially high risk for newborn infants (see symptoms below).

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 body 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.


Product Images

Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)
Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)
Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)

Case Counts

Total Adverse Events: 4
Hospitalizations: 4
Reported Deaths: 2*
Illness Onset Date Range: 9/6/2021 – 1/4/2022
States with Adverse Events: MN (1), OH (2), TX (1)
Product Distribution: Nationwide and International
* Two deaths have been reported. Cronobacter infection may have contributed to the cause of death for both patients.

USA – Mystery Salmonella and Listeria Outbreaks sicken 75 in United States while infant formula kills 2

Food Poison Journal

The Food and Drug Administration has posted an increase in the number of patients in an outbreak of Listeria monocytogenes infections as it continues investigations into three other outbreaks.

The new patient count in the Listeria outbreak is 16, up from 14 reported a week ago. As of March 16 the FDA had not determined the cause of the outbreak. The agency has initiated traceback efforts, but has not revealed what food or foods are involved in those activities.

The FDA has not revealed any demographic information on the Listeria patients and has not reported where they live.

In other outbreak news the FDA is investigating a new outbreak of Salmonella SaintPaul infections that has sickened 59 people. The agency announced the outbreak on March 16. As with the Listeria outbreak investigation, the FDA has not released any patient information for the Salmonella outbreak and has not reported where the patients live. Traceback efforts have begun, according to the FDA, but the agency did not report what food or foods are involved.