Abbott Laboratories recalled some Similac PM 60/40 cans and cases produced at a Michigan facility, after an infant who was exposed to the powdered baby formula died, the U.S. Food and Drug Administration said on Monday.
A few days earlier, Abbott recalled certain Alimentum, Similac and EleCare baby formulas made at the facility in Sturgis city following complaints about bacterial infections in infants who consumed the products.
The FDA had then said it was investigating the consumer complaints.
The investigation included four reports of Cronobacter sakazakii infections in infants and one complaint of a Salmonella Newport infection in an infant, the federal agency said on Monday, adding that Cronobacter might have contributed to death in two patients.
Cronobacter sakazakii bacteria can cause serious invasive infections and premature infant death. The most recent U.S. outbreak spanned four states in 2011.
The recalled Similac PM 60/40 products were distributed to the United States and Israel, the federal agency said. It is working with Abbott on safely resuming production at the Michigan facility.
From the FDA:
The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:
- the first two digits of the code are 22 through 37; and
- the code on the container contains K8, SH or Z2; and
- the expiration date is 4-1-2022 (APR 2022) or later.