FDA investigates death of baby 'after drinking Abbott formula' less than a month after plant reopens

FDA investigates death of baby ‘after drinking Abbott formula’ less than a month after plant reopens

The Food and Drug Administration (FDA) is investigating after another child died after allegedly consuming infant formula produced by Abbott Laboratories.

An Abbott spokesperson told DailyMail.com that the company received “limited clinical and product information” to evaluate the case and, at this time, “there are no conclusions” or “evidence to suggest a causal relationship” between the Abbott products. Abbott and the reported baby. death.

The investigation comes less than a month after the FDA gave Abbott the green light to reopen its factory in sturgis, Michigan. The plant is the largest baby formula factory in the US.

The facility was closed in February following bacterial contamination in four babies, including two who died. The investigation revealed that Abbott products were not likely the source of the infections in the earlier cases.

The Sturgis plant closed again more than a week ago after severe thunderstorms and torrential rain caused damage to the facility. The company said it needs time to assess the damage and re-sanitize the factory before reopening again.

In the meantime, the US continues to battle formula shortages across the country. The Biden administration announced Wednesday that officials are providing logistical support to import about 16 million 8-ounce bottles of baby formula from Mexico starting this weekend.

The move is part of President Joe Biden’s Operation Fly Formula initiative aimed at easing supply-shortage disruptions intensified by the closure of the Abbott plant.

The Food and Drug Administration (FDA) is investigating after another child died after allegedly consuming infant formula produced by Abbott Laboratories.

The latest infant death occurred in January, according to a consumer complaint submitted to the FDA on June 10.

The agency did not specify which Abbott product the child allegedly consumed or where the infant formula was produced, but noted that its investigation is still in the preliminary stage.

An Abbott spokesperson told DailyMail.com on Wednesday that the company was made aware of the infant death case last week.

However, the manufacturer of the formula alleges that “limited clinical and product information was provided to evaluate the case.”

“At this time, no conclusions or evidence can be drawn to suggest a causal relationship between Abbott’s formulas and this reported case,” the spokesperson said. “If additional information becomes available, we will investigate further in accordance with our complaint handling process.”

Abbott issued a formula recall in February 2022 after receiving multiple reports of infant deaths.

The FDA investigated nine reports of infant deaths, including seven that had not been made public before earlier this month, between December 2021 and March 2022, that had allegedly been linked to infant formula. The most recent case would mark the 10th alleged death.

The infant death reports were included in a list of 128 consumer complaints filed with the FDA. The complaints were made public by eFoodAlert on June 8.

Two of the deaths listed in the reports were among four confirmed cases of Cronobacter sakazakii identified by the CDC. The bacteria had reportedly been discovered at the Sturgis plant.

An Abbott spokesperson told DailyMail.com in May that a “thorough investigation” by the FDA and Abbott revealed that “infant formula produced at our Sturgis facility is not the likely source of infection in the reported cases and that there was no an outbreak caused by products from the facility’.

The other seven deaths were reported to the FDA, its consumer complaint system, and two mentioned Salmonella in the description of the complaint.

The FDA has said it was unable to find enough evidence linking those seven circumstances directly to the Abbott plant.

Meanwhile, national leaders are trying to ease a nationwide baby formula shortage that worsened after the Abbott factory closed in February.

Abbott recalled several leading formula brands at the time, including Similac. That reduced supplies that had already been affected by supply chain and storage disruptions during the COVID-19 closures.

The current formula shortage has been most severe for children with allergies, digestive problems and metabolic disorders who rely on special formulas.

The Biden administration announced Wednesday that it will import formula from Mexico starting this weekend.

The Department of Health and Human Services is expediting the journey of trucks that will transport about 1 million pounds of Gerber Good Start Gentle infant formula from a Nestlé plant to U.S. retailers, nearly double the amount imported into USA to date.

Cargo flights from Europe and Australia have already brought baby formula to the US, including two new rounds of air shipments starting this weekend.

Last month, the Food and Drug Administration moved to ease federal import regulations to allow infant formula to be shipped to the US.

Biden also authorized the use of the Defense Production Act to provide federal support to move formula from overseas to the US.

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