Abbott today announced that the U.S. District Court for the Western District of Michigan has amended the recent consent decree allowing Abbott to release limited quantities of its EleCare® specialty amino acid-based formulas that were previously on hold following the Feb. 17 recall of some powder infant formulas from its Sturgis, Mich., facility. The consent decree was amended at the request of Abbott and the U.S. Food and Drug Administration (FDA) to enable the company to get EleCare to children in urgent medical need. These EleCare product batches were on hold pursuant to an agreement with the FDA.
All products have been tested and meet all product release requirements. In addition, Abbott has concluded additional, enhanced testing to provide assurance the product is safe to distribute. Abbott plans to restart production at the Sturgis facility on June 4 and will prioritize EleCare production, with initial EleCare product release to consumers beginning on or about June 20.
EleCare formulas are hypoallergenic and are used by infants and children who have severe food allergies or gastrointestinal (GI) disorders that require amino acid-based formulas. While Abbott has limited inventory of these products, there should be enough to fulfill current patient needs until new product is available in the coming months. The products being released are EleCare (for infants 0-12 months) and EleCare Jr (for ages one year and up).
Similac® and Alimentum® powder formulas that were voluntarily recalled in February are not included in this product release.
What Parents, Caregivers and Healthcare Professionals Should Do
EleCare products are used under the care of a healthcare professional. Parents and caregivers in urgent need should contact their healthcare professionals or Abbott at +1-800-881-0876 for additional information.
Abbott will fulfill requests to the best of its ability and as quickly as possible. Abbott expects to begin shipping product within the next several days. Product will be shipped directly to healthcare professionals, hospitals or consumers. Once production resumes in the Sturgis facility, Abbott will prioritize manufacturing of EleCare and other specialty and metabolic formulas to restock supplies as quickly as possible.
“Releasing this product immediately will help families impacted by the lack of availability of EleCare,” said Robert B. Ford, chairman and chief executive officer, Abbott. “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.”
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