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FDA details problems at plant behind recalled baby formula

Abbott-Alere-Acquisition
Posted at 9:21 AM, Mar 23, 2022
and last updated 2022-03-23 11:47:12-04

WASHINGTON (AP) — Federal safety inspectors say baby formula maker Abbott failed to maintain sanitary conditions at the Michigan manufacturing plant recently linked to a cluster of infant illnesses.

The Food and Drug Administration began investigating the plant after Abbott recalled several leading infant formulas.

The products have been tied to four infant hospitalizations due to a rare bacterial infection, including two deaths.

FDA inspectors released their initial findings Tuesday evening.

Among other problems, they found a history of contamination with the bacteria in various plant parts.

But the FDA report doesn't identify a root cause for the latest outbreak.

On Feb. 17, Abbott initially recalled certain Alimentum, Similac, and EleCare baby formulas made at its Sturgis, Michigan, facility.

Then on Feb. 28, the FDA announced that the recall had been expanded to include one lot of Similac PM 60/40.

Health officials said their investigation included four reports of Cronobacter sakazakii infections in infants (three from FDA complaints and one from a CDC case finding) and one complaint of a Salmonella Newport infection in an infant.

"All five (four Cronobacter infections and one Salmonella Newport infection) illnesses resulted in hospitalization, and Cronobacter may have contributed to death in two patients," the agency said.

The FDA said the formula for the most recent infant consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800 before being infected with Cronobacter.