Abbott Nutrition, the largest U.S. infant formula manufacturer, has reopened its baby formula plant in Sturgis, Michigan that was closed after reporting bacterial infections and related deaths in babies.
The resultant major recall of its most popular powder formulas, including Similac, Alimentum, and EleCare, had triggered the severe shortage for infant formula supplies in the United States.
Abbott tweeted, “We’re restarting production of our specialty infant formula, EleCare, at our Michigan facility. We understand the urgent need for formula and our top priority is getting high-quality, safe formula in the hands of families.”
The production of EleCare and other specialty and metabolic formulas at the plant was restarted after meeting initial requirements agreed to with the U.S. Food and Drug Administration as part of the consent decree entered into on May 16.
Initial EleCare product release to consumers will beginning on or about June 20. The company said it is working to restart production of Similac and other formulas as well.
Abbott had called back millions of powder formulas, including Similac, Alimentum, and EleCare, produced in its manufacturing facility in Sturgis, Michigan after four infants were diagnosed with Cronobacter sakazakii or Salmonella Newport, a rare bacterial infection, and two died.
The plant was closed down, and the investigation report by FDA noted that the facility failed to maintain sanitary conditions and procedures.
But, following the worst shortage of the baby formula products, the FDA in May agreed with Abbott to restart production at the plant, subject to court approval. Abbott then had confirmed that EleCare would be the first formula produced at the Sturgis facility when it restarts production, and other specialty metabolic formulas will closely follow.
The FDA also approved then the release of Abbott’s about 300,000 cans of EleCare amino acid-based infant formula previously produced at Abbott Nutrition’s Sturgis, Michigan, facility to individuals needing urgent, life-sustaining supplies of this specialty formula on a case-by-case basis. Before the release, the agency said these products would undergo enhanced microbiological testing.
Those EleCare products were not part of Abbott’s recent recall, and were in different lots, have never been released and have been maintained in storage under control by Abbott Nutrition.
During the plant closure period, Abbott, in order to mitigate the supply issues, air shipped millions of cans of infant formula powder into the U.S. from FDA-registered facility in Cootehill, Ireland. The company also prioritized infant formula production at Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed.
The Biden Administration also has taken various steps to meet the shortage. Under the third Operation Fly Formula Mission arranged by the U.S. Government, the country is importing more than 8 million bottles of baby food from Australia and the United Kingdom this week.
The FDA, which urged infant formula manufacturers worldwide to import products to the U.S., recently announced the intended availability of around 39.5 million additional bottles of infant formula from Swiss food major Nestle SA starting June through October.
Earlier, British nutrition products maker Kendal Nutricare agreed to send about 2 million cans of infant formula under the Kendamil brand initially to U.S. beginning in June.
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