Category Archives: Cronobacter sakazakii

USA – FDA issues warnings to water company over mold contamination and infant formula producer lacking Cronobacter testing

Posted on September 10, 2024 by | Leave a comment

Food Safety News

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

The U.S. Food and Drug Administration (FDA) recently issued warning letters to Waiakea Bottling Inc. and Graceleigh, Inc., doing business as Sammy’s Milk, for serious violations of food safety regulations. The violations pose potential risks to public health, emphasizing the need for compliance with FDA regulations.

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Posted in Cronobacter sakazakii, cross contamination, Decontamination Microbial, Food Micro Blog, mold, Mold Toxin, Mold/ MouldAscospores, Mould/Mold

Research – Systematic risk ranking of microbiological hazards in infant foods

Posted on August 26, 2024 by | Leave a comment

Science Direct

Abstract

Ensuring food safety, particularly for vulnerable groups, like infants and young children, requires identifying and prioritizing potential hazards in food chains. We previously developed a web-based decision support system (DSS) to identify specific microbiological hazards (MHs) in infant and toddler foods through a structured five-step process. This study takes the framework further by introducing systematic risk ranking (RR) steps to rank MH risks with seven criteria: process survival, recontamination, growth opportunity, meal preparation, hazard-food association evidence, food consumption habits of infants and toddlers in the EU, and MH severity. Each criterion is given a semi-quantitative or quantitative score or risk value, contributing to the final MH risk calculation via three aggregation methods: semi-quantitative risk scoring, semi-quantitative risk value, and outranking multi-criteria decision analysis (MCDA). To validate the criteria and ranking approaches, we conducted a case study to rank MH risks in infant formula, compared the results of the three risk ranking methods, and additionally evaluated the ranking results against expert opinions to ensure their accuracy. The results showed strong agreement among the three methods, consistently ranking Salmonella non-Typhi and Cronobacter spp. and Shiga-toxin-producing Escherichia coli as the top MH risks in infant formulae, with minor deviations. When MHs were ranked after an initial hazard identification step, all three methods produced nearly identical MH rankings, reinforcing the reliability of the ranking steps and the selected criteria. Notably, the risk value and MCDA methods provided more informative MH rankings compared to the risk scoring method. The risk value and risk scoring methods were implemented into an online tool, called the MIcrobiological hazards risk RAnking decision support system (Mira-DSS), available at https://foodmicrobiologywur.shinyapps.io/MIcrobial_hazards_RAnking/. In conclusion, our framework enables the ranking of MH risks, facilitating intervention comparisons and resource allocations to mitigate MH risks in infant foods, with potential applicability to broader food categories.

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Posted in Cronobacter sakazakii, Food Microbiology Research, Food Safety, Food Safety Management, Food Safety Regulations, food safety training, Research, Salmonella, STEC, STEC E.coli

Research – Fighting Cronobacter will go far beyond infant formula

Posted on August 14, 2024 by | Leave a comment

Lex Blog

The 2022 infant formula crisis focused renewed attention on the dangers posed by Cronobacter infections to newborns, but recent research has made clear that reducing these risks may be significantly more complex than many of us anticipated.

This conclusion is based on a better understanding of the ecology of the pathogen and, in particular, the results of a recent study released by IEH Laboratories, which provides a further understanding of the bacterial pathogen itself by finding it in the home environment and other foods. It’s become evident that the link between Cronobacter sakazakii and powdered infant formula (PIF) might not be as straightforward as we originally thought. While the conventional narrative has pointed to the production environment as the source of the pathogen, this new research suggests that the home environment and foods also may play a role.

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Posted in Cronobacter sakazakii, Food Microbiology Research, Research

Canada – Gerber® brand Oat Banana & Mango Baby Cereal recalled due to Cronobacter spp.

Posted on August 5, 2024 by | Leave a comment

Gov Canada

Summary

Product
Oat Banana & Mango Baby Cereal
Issue
Food – Microbial Contamination – Other
What to do

Do not consume, use, sell, serve, or distribute recalled products

Distribution
Online
Alberta
British Columbia
Manitoba
New Brunswick
Ontario
Quebec
Saskatchewan
Possibly other provinces and territories
Gerber - Oat Banana & Mango Baby Cereal - 227 g - Front
Gerber - Oat Banana & Mango Baby Cereal - 227 g - Lot code

The affected product is being recalled from the marketplace due to possible Cronobacter spp. contamination.

What you should do

  • If you think you became sick from consuming a recalled product, contact your healthcare provider
  • Check to see if you have recalled products
  • Do not consume, serve, use, sell, or distribute recalled products
  • Recalled products should be thrown out or returned to the location where they were purchased

Food contaminated with Cronobacter may not look or smell spoiled but can still make you sick. Although Cronobacter is not commonly linked to human illness, in rare cases it can cause serious or fatal infections. Cronobacter can cause rare bloodstream and central nervous system infections and has been associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (sepsis), especially in newborns.

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Posted in Cronobacter sakazakii, cross contamination, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Temperature Abuse, Food Testing, foodbourne outbreak

Canada – Update – Baby Gourmet Organic brand Banana raisin oatmeal organic whole grain baby cereal recalled due to Cronobacter spp

Posted on August 2, 2024 by | Leave a comment

Gov Canada

Summary

Product
Banana raisin oatmeal organic whole grain baby cereal
Issue
Food – Microbial Contamination – Other
What to do

Do not consume, use, sell, serve, or distribute recalled products

Distribution
National
Baby Gourmet Organic - Banana raisin oatmeal baby cereal - 227 g - Front
Baby Gourmet Organic - Banana raisin oatmeal baby cereal - 227 g - Back
Baby Gourmet Organic - Banana raisin oatmeal baby cereal - 227 g - Code
Baby Gourmet Organic - Banana raisin oatmeal baby cereal - 227 g - UPC

The food recall warning issued on 2024-07-20 has been updated to include additional product information, marked by an asterisk (*).

The affected product is being recalled from the marketplace due to possible Cronobacter spp. contamination.

What you should do

  • If you think you became sick from consuming a recalled product, contact your healthcare provider
  • Check to see if you have recalled products
  • Do not consume, serve, use, sell, or distribute recalled products
  • Recalled products should be thrown out or returned to the location where they were purchased

Food contaminated with Cronobacter may not look or smell spoiled but can still make you sick. Although Cronobacter is not commonly linked to human illness, in rare cases it can cause serious or fatal infections. Cronobacter can cause rare bloodstream and central nervous system infections and has been associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (sepsis), especially in newborns.

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Posted in CFIA, Cronobacter sakazakii, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing

USA – FDA Alerts Parents and Caregivers to Cronobacter Safety Concerns with Crecelac Goat Milk Infant Formula Imported and Distributed by Dairy Manufacturers Inc.

Posted on August 1, 2024 by | Leave a comment

FDA

Cerecelac Powdered Infant Formula

Cerecelac Powdered Infant Formula

Farmalac Powdered Infant Formula

Farmalac Powdered Infant Formula

What’s New

July 31, 2024

After conducting an abbreviated nutrient analysis of Crecelac Infant Powdered Goat Milk Infant Formula, the FDA found both elevated levels of potassium and chloride and low levels of Vitamin A. The potassium and chloride levels were significantly above the levels permitted in infant formula in the U.S. and could lead to kidney and/or heart problems if the infant formula is used for an extended period of time. In addition, low Vitamin A intake could lead to vision loss from a Vitamin A deficiency if the infant formula is used for an extended period of time.

As this product was part of a voluntary recall that the company initiated on May 24, 2024, all caregivers should have already disposed of the product and discontinued use. If you have continued to use this product, the FDA recommends discontinuing any further use. Parents and caregivers who used this product and have concerns should consult with their health care providers.

Audience

  • Parents and caregivers of infants who consume infant formula.

Summary of Problem and Scope

The FDA has determined that the infant formula products listed above were sold in the U.S. illegally because, among other things, the company has not submitted to the FDA the required premarket notification.

On May 21, 2024, the FDA recommended that the firm recall the infant formula products to which the firm agreed. As the FDA continued its investigation, the agency identified Cronobacter in a sample of the recalled Crecelac infant formula product. The FDA notified Dairy Manufacturers Inc. of these findings and they agreed to update their recall press release to include the laboratory results.

The FDA is continuing to work with the firm and its distributors to ensure the recall is effectively executed.

Further Information for Consumers

The FDA is issuing this advisory because infants that consume these products could be at risk of potentially severe infection due to the Cronobacter contamination. The FDA advises parents and caregivers not to feed these infant formula products to infants under their care. 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.

If caregivers are looking for an alternative goat milk infant formula for sale in the U.S., they may wish to speak with their infant’s health care provider, as there are goat milk infant formulas that either have completed the required FDA premarket notification process or are currently being marketed under the FDA’s enforcement discretion policy.

Additionally, parents and caregivers can find more information on safe infant feeding practices on the FDA’s infant formula landing page.

Recommendation for Consumers

To report a complaint or adverse event (illness or serious allergic reaction), you can:

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Posted in Cronobacter sakazakii, cross contamination, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing

Canada – Baby Gourmet Organic brand Banana raisin oatmeal organic whole grain baby cereal recalled due to Cronobacter spp.

Posted on July 22, 2024 by | Leave a comment

Gov Canada

Product
Banana raisin oatmeal organic whole grain baby cereal
Issue
Food – Microbial Contamination – Other
What to do

Do not consume, use, sell, serve, or distribute recalled products

Distribution
National
Baby Gourmet Organic - Banana raisin oatmeal baby cereal - 227 g - Front
Baby Gourmet Organic - Banana raisin oatmeal baby cereal - 227 g - Back
Baby Gourmet Organic - Banana raisin oatmeal baby cereal - 227 g - Code
Baby Gourmet Organic - Banana raisin oatmeal baby cereal - 227 g - UPC

The affected product is being recalled from the marketplace due to possible Cronobacter spp. contamination.

What you should do

  • If you think you became sick from consuming a recalled product, contact your healthcare provider
  • Check to see if you have recalled products
  • Do not consume, serve, use, sell, or distribute recalled products
  • Recalled products should be thrown out or returned to the location where they were purchased

Food contaminated with Cronobacter may not look or smell spoiled but can still make you sick. Although Cronobacter is not commonly linked to human illness, in rare cases it can cause serious or fatal infections. Cronobacter can cause rare bloodstream and central nervous system infections and has been associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (sepsis), especially in newborns.

Leave a comment

Posted in CFIA, Cronobacter sakazakii, cross contamination, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Research, Food Microbiology Testing, Food Pathogen, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing

USA – Dairy Manufacturers Inc. Is Notifying Consumers About a Safety Concern With Crecelac Infant 0-12 Infant Formula (Lot # 24 039 1 CHE 352-1) That is Part of an Ongoing Recall – Expansion of Previous Recall – Cronobacter

Posted on June 5, 2024 by | Leave a comment

FDA

Crecelac 0-12 Lot #: 24 039 1 CHE 352-1, Front label, Back label, Use by AUG2025

Dairy Manufacturers Inc., of Prosper, TX – 6/3/24, is notifying consumers about a safety issue associated with a product that is an extension of an ongoing voluntary recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dairy-manufacturers-inc-issues-voluntary-recall-products-due-non-compliance-requirements-under-21). D-M initiated a voluntary recall on 05/24/24. Crecelac Infant 0-12 with an expiration date of 08/2025 was manufactured at D.M. Mexicana Sa De Cv in Monterey, Mexico and is part of this ongoing recall. D-M is now alerting consumers that a sample of this product has tested positive for Cronobacter spp.

Cronobacter is a bacterium that can cause bloodstream and central nervous system infections, such as sepsis and meningitis, respectively. Complications from Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death.

Symptoms of Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.

Crecelac 12.4 oz containers were distributed primarily in March, April, and May of 2024. The product was distributed through retail stores in the state of Texas only. The recalled product is labeled as infant formula and packaged in a 12.4 oz. cardboard and aluminum can.

Only the lot listed below had samples containing Cronobacter spp.

PRODUCT

UPC

LOT CODE

EXP. DATE
Crecelac Infant 0-12 8 50042 40847 6 24 039 1 CHE 352-1 08/2025

The recalled product can be identified by the batch code on the bottom of the can.

There have been no reports of injuries or adverse reactions due to consumption of these products.

Consumers who have purchased Crecelac Infant 0-12, should discontinue use of the recalled product and return it to the place of purchase for a full refund. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers with questions may contact the company at 1-972-347-2341 (Monday to Friday, 9:30 a.m. to 5 p.m. EST).

This recall is being made with the knowledge of the Food and Drug Administration.

We sincerely apologize for any inconvenience or concern this may cause and assure our customers that we are taking all necessary steps to ensure the safety, quality, and compliance of our products.

Link to Initial Press Release

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Posted in Cronobacter sakazakii, FDA, food contamination, food handler, Food Hazard, Food Hygiene, Food Inspections, Food Micro Blog, Food Microbiology, Food Microbiology Blog, Food Microbiology Testing, Food Pathogen, Food Quality, food recall, Food Safety, Food Safety Alert, Food Safety Management, Food Safety Regulations, Food Testing

USA – FDA Alerts Parents and Caregivers to Cronobacter Safety Concerns with Crecelac Goat Milk Infant Formula Imported and Distributed by Dairy Manufacturers Inc.

Posted on June 3, 2024 by | Leave a comment

FDA

Cerecelac Powdered Infant Formula

Cerecelac Powdered Infant Formula

Farmalac Powdered Infant Formula

Farmalac Powdered Infant Formula

Audience

  • Parents and caregivers of infants who consume infant formula.

Products

  • CRECELAC INFANT Powdered Goat-Milk Infant Formula with Iron 0 to 12 months – Net Wt. 12.4 oz (352g)
  • Farmalac BABY Powdered Infant Formula with Iron 0 to 12 months Net Wt. 12.4 oz (352g)
  • Farmalac BABY Powdered Infant Formula with Iron Low Lactose 0 to 12 months Net Wt. 12.4 oz (352g)

Products are being sold at some retail stores in Texas and, possibly, additional locations in the U.S.

The U.S. Food and Drug Administration (FDA) is alerting parents and caregivers about Cronobacter safety concerns with Crecelac Infant Powdered Goat Milk Infant Formula and other infant formula products imported and distributed by Dairy Manufacturers Inc. Although the company initiated a recall of the products referenced above on May 24, 2024, because they were not in compliance with all of the FDA’s infant formula regulations, the FDA is now issuing this safety alert due to new findings of Cronobacter contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula. As part of its investigation into this matter, on May 29, 2024, the FDA found Cronobacter in a sample of Crecelac Infant Powdered Goat Milk Infant Formula collected from a retail store in Texas.

Separately, the FDA is also alerting parents and caregivers to a recall initiated by Dairy Manufacturers Inc. of the Farmalac products listed above because of their failure to meet U.S. infant formula regulations. Limited sampling of the Farmalac products did not detect Cronobacter; however, the firm has not submitted the required premarket notification to the FDA to demonstrate the safety and nutritional adequacy of the infant formula. The FDA is continuing to work with the firm and its distributors to ensure the recall is effectively executed.

Cronobacter is a bacterium that can cause bloodstream and central nervous system infections, such as sepsis and meningitis, respectively. Complications from Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death.

Symptoms of Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.

At this time, the FDA is not aware of any illnesses associated with these products and the FDA does not anticipate any impact on the supply of infant formula based on the recall of these products.

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Posted in Cronobacter sakazakii, cross contamination, FDA, food recall, product recall, Recall

Research – Long chain unsaturated fatty acids alter growth and reduce biofilm formation of Cronobacter sakazakii

Posted on May 10, 2024 by | Leave a comment

Wiley Online

Cronobacter sakazakii is a foodborne pathogen predominately transmitted through contaminated dried foods and affects populations including neonates, infants, and the elderly. Following several recent outbreaks, it is now a notifiable infection in those under 12 months of age. Current control methods include strict manufacturing guidelines, with monitoring of this genus a legal requirement in powdered infant formula production. Fatty acids have long been known as antimicrobials, with long-chain fatty acids increasingly identified as agents that target virulence factors. This study gives insight into the changes promoted by three long-chain unsaturated fatty acids (oleic, linoleic, and α-linolenic) on C. sakazakii growth, morphology, and biofilm formation. Each fatty acid was individually introduced to C. sakazakii 29544 both as a sole carbon source and as an addition to complex media. Following comparison to the untreated control, bacterial cells treated with these fatty acids showed a significant and media-dependent impact on growth and biofilm inhibition. With further characterization, long-chain fatty acids, including α-linolenic acid, could be utilized as a control method with minimal safety constraints regarding their use in the food production environment.

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Posted in Cronobacter sakazakii, cross contamination, Decontamination Microbial, Food Microbiology Research, Food Pathogen, Food Technology, Pathogen, pathogenic, Research, Technology