U.S. FDA Issues Urgent Warning About Infant Formulas Contaminated with Cronobacter!
Nikhil Prasad Fact checked by:Thailand Medical News Team Jun 02, 2024 1 month, 3 weeks, 3 days, 13 hours, 59 minutes ago
Medical News: FDA Alerts Parents and Caregivers
The U.S. Food and Drug Administration (FDA) has issued an urgent safety alert to parents and caregivers concerning potential Cronobacter contamination in Crecelac Infant Powdered Goat Milk Infant Formula and other infant formula products imported and distributed by Dairy Manufacturers Inc. This warning follows a voluntary recall by the company on May 24, 2024, due to non-compliance with FDA infant formula regulations. However, the FDA is now highlighting new findings of Cronobacter contamination in a sample of Crecelac formula. The U.S. FDA has also sent out press releases to various mainstream news media and also
Medical News sites on this issue.
U.S. FDA Issues Urgent Warning About Infant Formulas Contaminated with Cronobacter
Cronobacter Contamination Discovered
On May 29, 2024, the FDA's investigation revealed the presence of Cronobacter in a sample of Crecelac Infant Powdered Goat Milk Infant Formula obtained from a retail store in Texas. Concurrently, the FDA is also informing the public about a recall initiated by Dairy Manufacturers Inc. concerning Farmalac products, which similarly failed to meet U.S. infant formula regulations. The company did not submit the required premarket notification to the FDA to verify the safety and nutritional adequacy of the formulas.
Understanding Cronobacter and Its Risks
Cronobacter is a bacterium that poses serious health risks, particularly to infants. It can cause severe bloodstream infections (sepsis) and central nervous system infections, such as meningitis. Infected infants might suffer from brain abscesses, developmental delays, motor impairments, and, in the worst cases, death. Symptoms of Cronobacter infection in infants include poor feeding, irritability, temperature changes, jaundice, grunting breaths, and abnormal body movements.
No Reported Illnesses Yet, But Caution Advised
As of now, the FDA has not received any reports of illnesses related to these products and does not foresee any impact on the overall supply of infant formula due to the recall. Despite this, the FDA stresses the potential risk of severe infection from Cronobacter contamination and advises parents and caregivers to avoid feeding the affected products to their infants. Immediate medical attention is recommended if any symptoms of Cronobacter infection are observed.
Dairy Manufacturers Inc. Voluntary Recall Details
On May 24, 2024, Dairy Manufacturers Inc., based in Prosper, Texas, announced a voluntary recall of all lot codes for the following infant formulas: Crecelac Infant 0-12, Farmalac 0-12, and Farmalac 0-12 Low Lactose. These products, sold only in Texas, were found to be non-compliant with FDA regulations under section 21 CFR 106.110, which pertains to new infant formula registration. The recall includes products with the following details:
Crecelac Infant 0-12: UPC 8 50042 40847 6, Exp. Dates 08/2025 and 09/2025
Farmalac 0-12: UPC 8 50042 40841 4,
Exp. Dates 08/2025 and 09/2025
Farmalac 0-12 Low Lactose: UPC 8 50042 40839 1, Exp. Dates 08/2025 and 09/2025
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dairy-manufacturers-inc-issues-voluntary-recall-products-due-non-compliance-requirements-under-21
Refunds and Consumer Guidance
Consumers who have purchased these products are urged to discontinue their use immediately and return them to the place of purchase for a full refund. No injuries or adverse reactions have been reported thus far. Consumers with concerns about potential injuries or illnesses should contact their healthcare provider.
Company's Apology and Contact Information
Dairy Manufacturers Inc. has expressed sincere apologies for any inconvenience and concern caused by this issue. They assure customers that all necessary measures are being taken to ensure the safety, quality, and compliance of their products. For further inquiries, consumers can contact the company at 1-972-347-2341, available Monday to Friday from 9:30 a.m. to 5 p.m. EST.
U.S.FDA's Commitment to Safety
The FDA remains committed to ensuring the safety and well-being of infants and continues to work closely with Dairy Manufacturers Inc. and its distributors to ensure the effective execution of the recall. Parents and caregivers looking for alternative goat milk infant formulas should consult their infant’s healthcare provider to find safe and compliant options available in the U.S.
By staying informed and taking prompt action, parents and caregivers can help protect their infants from potential health risks associated with contaminated infant formulas.
For more Product Recalls Or Medical Alerts, keep on logging to Thailand
Medical News.
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