Abbott Laboratories said it could have some of its recalled infant formulas back on store shelves within eight to 10 weeks after the U.S. Food and Drug Administration gives its approval, though it’s unclear when that approval may come.
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For months, parents and babies have endured a nationwide shortage of infant formulas, partly linked to Abbott’s February recall of Similac, Similac Alimentum and EleCare powder formulas made at a Sturgis, Michigan, facility as the FDA investigated complaints of Cronobacter sakazakii infections among four babies who reportedly consumed formula made there. All four babies were hospitalized, and Cronobacter may have contributed to two babies’ death, according to the FDA.
North suburban-based Abbott said in a statement Wednesday that it has taken action to address issues in its Sturgis plant, and it could restart production there within two weeks of getting approval from the FDA. Once it has that approval, it would first produce EleCare, Similac Alimentum and metabolic formulas, which are formulas for babies with special nutritional needs. It would then resume production of Similac and other formulas, according to the statement. Once production is restarted, it would take six to eight weeks before the products would return to stores.
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“We understand the situation is urgent — getting Sturgis up and running will help alleviate this shortage,” Abbott said in the statement.
It’s not clear, however, exactly when the FDA will give Abbott a green light to restart production at the facility.
The FDA said in a statement Thursday that it recognizes consumers are frustrated that they can’t find many types of formula, and the FDA is “doing everything in its power to ensure there is adequate product available where and when they need it.”
“At the same time, it is important that the FDA continue its work to ensure that Abbott can undertake safe resumption of production of infant formula at Abbott Nutrition’s Sturgis, Michigan facility, to further alleviate these supply challenges, which remains an important focus,” the FDA statement said. “The plant remains closed as the company works to correct findings related to the processes, procedures, and conditions that the FDA observed during its inspection of the facility from January 31 – March 18, 2022.”
During that inspection, the FDA found five environmental subsamples collected from the Sturgis facility to be positive for Cronobacter sakazakii, though product samples collected by the FDA at the facility were negative for Cronobacter.
Abbott said the Cronobacter that was found in environmental testing during the investigation was in “non-product contact areas of the facility and has not been linked to any known infant illness.”
Abbott said it has reviewed and updated its education, training and safety procedures for employees and visitors; updated its protocols related to water and cleaning and maintenance procedures; and has been upgrading the plant, including by installing nonporous, “easily cleanable and sanitary floors.”
Abbott is facing a number of lawsuits filed by parents over the recalled formulas.
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Parents in Illinois and across the country are eager to see an end to the formula shortage, which has been partly caused by supply chain issues. Formulas made by Abbott are not the only ones in short supply.
Many grocery stores and retail pharmacy chains, including Jewel-Osco, Walgreens and CVS Health, are limiting how much formula people can buy at once.
In the Chicago area, about 34% of formulas were out of stock at local stores the first week of May, up from 28% at the beginning of March, according to Datasembly, a company that scrapes data from retailers’ publicly available websites and apps to gauge product availability. During the first half of 2021, only about 2% to 8% of formulas were out of stock nationwide.
The FDA said in a news release earlier this week that it’s been meeting with major infant formula manufacturers to understand their capacity to increase production, and several companies are already working to ramp up production. It also said that even before the Abbott recall it was “working to address supply chain issues associated with the pandemic including those impacting the infant formula industry.”
The FDA has said parents should never dilute formula, use homemade formula or buy imported formula online, as it could be counterfeit. If a baby or child’s regular formula isn’t available, the FDA advises parents to talk with their pediatricians for recommendations.
