- 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