US Food and Drug Administration officials are investigating the death of another infant who was given formula made by Abbott Laboratories.
The infant died in January and the FDA was notified June 10, according to a statement from the agency Wednesday.
The FDA said:
The investigation of this most recent consumer complaint is in its preliminary stages and the agency will provide an update as it learns more.
Abbott shares shed some gains on the news and were up 1% at the close in New York.
Cronobacter bacteria were found in the infant at the time of death, the FDA said in an email. The agency later added that, while the complaint mentions cronobacter, the investigation is still early and no determination has been made. Four babies who previously became ill after receiving Abbott formula also had cronobacter infections.
The company said in a statement:
At this time, with the limited product and clinical information Abbott was provided to evaluate the case, there are no conclusions that can be drawn and no evidence to suggest a causal relationship between Abbott’s formulas and this reported case.
As previously reported, Abbott recalled formula, including widely used Similac, in February after the four babies became ill after consuming products made at the company’s plant in Sturgis, Michigan. Two of the infants died. The FDA said it hasn’t been able to definitively determine whether Abbott’s formula was the reason for the illnesses or deaths.
Abbott has also said there is no conclusive evidence to link its formula to the illnesses or deaths. Samples of formula batches are taken before distribution to conduct microbiological testing, and no formula made available to consumers tested positive for cronobacter, the company said Wednesday in an email.
The FDA also inspected the facility in February and March and found unsanitary conditions that led the plant to shut down until Abbott could fix the problems. Strains of cronobacter the FDA found at the Sturgis plant did not match the strains from two available samples from ill infants, Abbott has said. The plant reopened earlier this month only to be beset by flood waters that halted its infant formula production last week.
