In a significant move to ensure consumer safety, Dairy Manufacturers Inc., based in Prosper, Texas, has initiated a comprehensive recall of their infant formula products. This recall affects all lot codes of three specific products widely distributed in the U.S.: Crecelac Infant 0-12, Farmalac 0-12, and Farmalac 0-12 Low Lactose.
This action follows an alert from the U.S. Food and Drug Administration (FDA) which noted that these products were sold without meeting strict regulatory requirements.
Infant Formula Recall: FDA Regulations and Compliance
The FDA’s stringent regulations for infant formula are designed to safeguard babies by ensuring that all products sold in the U.S. adhere to the highest standards of safety and nutritional adequacy. The recalled products, unfortunately, were marketed in violation of section 21 of the FDA’s Code of Federal Regulations. This specific section mandates manufacturers to register with the FDA and submit a premarket notification before introducing a new infant formula to the market. The oversight was flagged following an FDA notification highlighting that the required premarket notification had not been submitted by Dairy Manufacturers Inc.
Immediate Actions for Consumers
For parents and caregivers, the immediate advice is to cease the use of these recalled products. The formulas in question are packaged in 12.4-ounce cans made of cardboard and aluminum, with expiry dates listed for August and September 2025. Although no illnesses have been linked to the products to date, the absence of FDA evaluation raises concerns about their safety and nutritional content. Consumers who have purchased any of the recalled formulas are encouraged to return them to the purchase location for a full refund.
In 2008, a Chinese milk company intentionally tainted baby formula powder so they could pass quality control tests.
At least six infants died, and hundreds of thousands more got sick.
This is milk producer and trader Geng Jinping begging for forgiveness during his trial. He… pic.twitter.com/vZOYLYuo3j
— Fascinating (@fasc1nate) March 22, 2024
Company’s Response and Consumer Information
Dairy Manufacturers Inc. has issued an apology for the inconvenience and concern caused by this recall. The company has reassured its customers of its commitment to take all necessary steps to ensure the safety, quality, and compliance of its products. For further information or assistance, customers can contact Dairy Manufacturers Inc. directly at 1-972-347-2341 during business hours, Monday to Friday, from 9:30 a.m. to 5 p.m. ET.
Broader Implications and Consumer Safety
This incident is part of a broader context where product recalls are becoming increasingly common, highlighting ongoing concerns about product safety in the market. Earlier this month, another recall was issued by a Washington-based company for a Goat Milk Formula Recipe Kit, advised by the FDA due to insufficient nutritional content when used as an infant formula. These instances underline the critical nature of regulatory compliance and the vigilance required to protect the youngest and most vulnerable consumers.
As families navigate these challenging situations, staying informed through reliable sources and adhering to guidance from health authorities and manufacturers is paramount. The ongoing commitment of regulatory bodies like the FDA ensures that standards are maintained and public health is protected.
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