The complaint, one of 129 related to Abbott’s formula, reported the January death six months later.
“At this time there is very little clinical or product information available to Abbott,” an Abbott spokesperson told Becker’s. “It is our understanding the consumer was unable to provide lot, UPC or date information, and no samples are available for testing. If additional information about this case becomes available, we will further investigate the case.”
Last month, the agency wrapped its first investigation into two children’s deaths after they consumed the product manufactured in Abbott’s Sturgis, Mich., factory. The FDA said “the evidence does not rule in or rule out a definitive link between these infant deaths” and the plant.
The other seven reports of deaths did not meet the FDA’s criteria to prompt an investigation.
Abbott’s Sturgis plant, which closed in mid-February and recalled its products, reopened June 4 only to shut down again less than two weeks later after severe storms flooded parts of the factory.
Editor’s note: This article was updated June 28 at 11:30 a.m. CT to include additional information from Abbott.
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