Abbott Laboratories plans to restart production of infant formula at its Michigan facility June 4, and it will begin releasing specialty formula EleCare in the next several days, the company said Tuesday.
The announcement comes amid a nationwide shortage of infant formula caused by supply chain issues and exacerbated by a recall of formulas made at Abbott’s Sturgis, Mich., facility.
Advertisement
Abbott recalled a number of infant formulas produced at that facility in February as the U.S. Food and Drug Administration announced that it was investigating complaints of Cronobacter sakazakii infections among four babies who reportedly consumed formula made there. All four were hospitalized, and Cronobacter may have contributed to two babies’ deaths, according to the FDA.
The FDA inspected the facility from Jan. 31 through March 18 and 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.
Advertisement
Abbott has 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 has said it has taken action to address issues with processes and procedures found during the FDA inspection.
Earlier this month, Abbott entered into a consent decree with the FDA outlining steps the company would have to take before it could restart production of infant formula at a Michigan facility.
Abbott said Tuesday it will also immediately begin releasing limited quantities of EleCare specialty formulas that were on hold following the recall. Many infants and some older children rely on EleCare formulas to meet their nutritional needs because of certain allergies or gastrointestinal disorders. Some older children with medical conditions, including in Illinois, have had to be hospitalized because of difficulty finding EleCare.
“All products have been tested and meet all product release requirements,” Abbott said in a news release Tuesday of the EleCare it will release. “In addition, Abbott has concluded additional, enhanced testing to provide assurance the product is safe to distribute.”
Abbott said it expects to begin shipping the EleCare in the next several days to health care professionals, hospitals and consumers. Parents and caregivers who need EleCare should contact their health care professionals or Abbott at 1-800-881-0876 for more information.
The announcement Tuesday comes just a day before an Abbott executive is expected to testify about the formula recall before the House Energy and Commerce Oversight and Investigations panel. It also came the same day that the Federal Trade Commission announced it was launching an inquiry into the formula shortage and ”the factors that have led to concentration in the infant formula market and the fragility of the supply chains for these crucial products,” according to an FTC news release.
Abbott CEO Robert Ford apologized in an op-ed in The Washington Post over the weekend for Abbott’s role in the formula shortage.
Ford said in an Abbott news release Tuesday, of the EleCare release: “Releasing this product immediately will help families impacted by the lack of availability of EleCare. When we restart our Sturgis facility the first week in June, we will produce EleCare first and make enough so that several months of supply will be available.”
