The U.S. Food and Drug Administration said another infant who died was exposed to formula made at Abbott Laboratories Inc.’s facility in Sturgis, Michigan, and that the company has voluntarily expanded its previously announced recall.
The FDA said that a Cronobacter sakazakii infection may have been a contributing cause of death for the baby, who consumed Similac PM 60/40 formula that hadn’t been recalled. After the FDA and Centers for Disease Control and Prevention informed the company, Abbott broadened its recall to include that lot of formula.
The FDA and the CDC are investigating four reports of Cronobacter infections and one report of salmonella infection in babies. All babies required hospitalization and two have died.
The FDA started investigating the Michigan facility on Feb. 17, following reports of infant illnesses after consuming the formula.
The agency said that it has begun on-site inspections, and has found positive Cronobacter sakazakii results from environmental samples, as well as internal records that indicate Abbott has disposed of products because of such contamination in the past.
The FDA urged consumers not to use Similac, Alimentum or EleCare powdered infant formula if the first two digits of its code are between 22 and 37, the code on the container includes “K8,” “SH” or “Z2,” and the expiration date is April 1 or later.
Cronobacter bacteria can cause severe and life-threatening infections, including inflammation of the membranes that protect the brain and spine, and can cause bowel damage.
The day after the FDA’s investigation announcement, Abbott was hit with a proposed class action brought by purchasers of infant formula accusing the company of allowing tainted formula to make it to the market.
Plaintiff Luis Alfredo Suarez alleges that his daughter, identified in the suit as A.S., ingested formula from one of the tainted batches, and developed symptoms of gastrointestinal distress as a result.
He aims to represent a nationwide class of buyers who experienced personal injuries as a result of the allegedly tainted baby formula, with claims of strict product liability and breach of warranty.
Suarez purchased Alimentum baby formula on Jan. 30 that had a lot number and expiration date that matched what the FDA identified in its release as the tainted lots, and his daughter continues to experience symptoms of gastrointestinal distress weeks later.