The U.S. Food and Drug Administration (FDA) said Wednesday that it had begun an investigation after being notified of another sudden infant death in January, which may be related to Abbott Laboratories’ ABT.N infant formula.
Abbott began recalling infant formula products in February and closed its Michigan plant following reports of a serious bacterial infection in four babies. This exacerbated the shortage between multiple manufacturers that started with a pandemic supply chain problem.
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The FDA has previously received reports of nine infant deaths, two of which were associated with a Michigan botanical survey. The health agency added that the study could not establish or rule out a direct link between the fatalities and the prescriptions produced at the factory.
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Abbott added on Thursday that there is currently no evidence to suggest a link between death and its formula, and that clinical and product information provided when the FDA notified the company last week was limited.
The company said it would investigate further when additional data became available.
(Report by Amruta Khandekar, edited by Shounak Dasgupta)
FDA investigating another sudden infant death that may be related to Abbott’s infant formula-nationwide
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