A federal judge has ordered a major baby formula recall after the discovery of a series of serious health problems in the products made by the Abbott plant. The recall came after a series of complaints from concerned parents and a 34-page report filed with the FDA alleging repeated violations of regulations, including failing equipment that allowed bacteria to reach the formula. The recall of Mead’s Enfamil and Abbott’s Sturgis facility was one of several contributing factors to the current shortage of baby formula.
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Mead’s Enfamil
A judge has ordered Mead to recall its popular infant formula. Mead has been under fire for producing a product that is contaminated with the bacteria Cronobacter sakazakii, also known as Enterobacter. The CDC and FDA have already ordered the company to recall its Enfamil infant formula, but the FDA did not recall the product itself.
Mead Johnson, the maker of Enfamil, has been sued in a federal court over the dangers of this infant formula Recalled Baby Formula. The infant formula is a cow’s milk-based product that was used in a NICU. Many premature babies have suffered from gastrointestinal problems as a result of Enfamil. While the FDA approved Enfamil, it has been linked to several cases of severe illness and even death.
In one case, a baby died after taking an Enfamil infant formula. The family notified the parents of the children in their care. The baby died from an infection caused by the formula. The second case in Missouri involves another brand of Enfamil, Lot ZP1K7G. The government has not ordered a recall for this powder because it was tested negative before it was shipped.
The lawsuit alleges that the baby’s stomach became obstructed by partially digested formula. The baby also developed severe neurological deterioration and underwent surgery to remove one-third of her intestines. The case has been transferred to the U.S. Judicial Panel on Multidistrict Litigation. In November, the company agreed to centralize the lawsuits, allowing the case to be heard in a single court.
The lawsuit was filed in a US court after the FDA found the milk powder to be contaminated with metal particles. Mead Johnson initially marketed the formula to physicians only, but it gained popularity quickly. Enfamil surpassed the company’s other products, including Similac PM 60/40, and became one of its most important products. There are 450 SKUs listed for the Enfamil brand globally, but the company is not releasing any specific numbers.
Abbott’s Sturgis facility
A federal judge has ordered major baby formula recalled from Abbott’s Sturgis facility after a recent complaint was filed by the U.S. Food and Drug Administration (F.D.A.). The investigation was brought about after an employee of the Sturgis facility filed a whistleblower complaint with the FDA claiming that the manufacturing facility did not destroy an entire batch of formula when it found the microorganisms. The former quality assurance worker claimed that senior management was under pressure to meet numbers and failed to disclose any of the details of the bacteria that were found.
The decision comes as a major blow to many parents. Hundreds of people are affected by the recall, including the workers at the Sturgis facility. Some of them are lifelong employees at the facility. If they’re affected, it will have a negative impact on the lives of those who rely on infant formula. Abbott has already halted production at the Sturgis facility but will return to it within two weeks.
The FDA inspectors found unsafe conditions in the baby formula building during their inspection in September 2021. The inspectors noted that there was no proper temperature control or proper equipment maintenance. According to the FDA whistleblower’s report, the manufacturing facility has failed to meet all FDA requirements. The agency’s findings are part of an effort by the company to boost infant formula availability. In addition to the recall, the federal government has announced new guidance regarding the importation of certain infant formula products.
In a final agreement reached by the agency, the U.S. government and Abbott have reached a legal agreement in which the company will restart production at the Sturgis facility. The FDA has not yet specified a timeline for the production to resume, but Abbott has stated that it will be at least two weeks before production resumes. During that time, the company will conduct several tests to ensure the safety of the product and reduce bacterial contamination.