Abbott to Release EleCare® Amino Acid-based Formulas to Help Meet Critical Patient Need
On May 24, 2022, Abbott announced the release of limited quantities of EleCare® specialty formulas, aimed at addressing urgent needs for children with severe food allergies. This action comes after U.S. District Court approval to amend a consent decree following a February recall. Abbott plans to restart production at its Sturgis facility on June 4, prioritizing EleCare manufacturing, with consumer availability expected by June 20. The product release is free of charge for affected families, while additional stocks will be produced to meet ongoing demand.
- Release of EleCare formulas to address critical patient needs.
- Production restart at Sturgis facility prioritized for EleCare.
- Products have passed testing and meet safety requirements.
- Limited inventory of EleCare may not cover all urgent needs until production ramps up.
- Abbott to release limited quantities of EleCare® branded specialty formulas
- Product will be released immediately free of charge to children in need
- Parents and caregivers in urgent need should contact their healthcare professionals or Abbott at +1-800-881-0876 for additional information
- 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
ABBOTT PARK, Ill., May 24, 2022 /PRNewswire/ -- Abbott (NYSE: ABT) 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."
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.
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SOURCE Abbott
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