FDA to allow release of 300,000 cans of Abbott’s EleCare infant formula

The US Food and Drug Administration said on Tuesday it would allow the release of about 300,000 cans of EleCare amino acid-based infant formula by Abbott Laboratories.

The formula was previously produced at Abbott Nutrition’s Sturgis, Michigan, facility. The regulator said it will be released to “individuals needing urgent, life-sustaining supplies” on a case-by-case basis.

Abbott in February recalled some baby formulas including Similac and closed its Sturgis manufacturing plant, creating one of the biggest infant formula shortages in recent history for US families.

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The biggest US supplier of powder baby formula shut its facility after reports of bacterial infections among four infants. It exacerbated a shortage among multiple manufacturers that began with supply-chain issues tied to the coronavirus pandemic.

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The FDA said it has informed UK’s Kendal Nutricare that the agency is exercising enforcement discretion for the import of certain infant formula under the Kendamil brand.

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The regulator said the UK-based company initially expects about 2 million cans to land on US store shelves beginning in June.

“Kendal Nutricare currently has over 40,000 cans in stock for immediate dispatch and the US Department of Health and Human Services has initiated conversations to evaluate options for getting the products to the US as quickly as possible,” the FDA said.

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