Abbott 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).