- Metabolic nutrition formulas previously on hold will be
released free of charge to patients, in coordination with
healthcare professionals based on need and on a case-by-case
basis
- The lots being released were not included in the February
recall and are now being released at the request of the U.S.
FDA
- Patients, caregivers and healthcare professionals with
questions should contact Abbott at +1-800-881-0876
ABBOTT
PARK, Ill., April 29,
2022 /PRNewswire/ -- At the request of the U.S. Food
and Drug Administration (FDA), Abbott (NYSE: ABT) is releasing
limited quantities of metabolic nutrition formulas that were
previously on hold following Abbott's recall of some powder infant
formulas from its Sturgis, Mich.,
facility. The products have been tested and comply with all product
release requirements before distribution. The lots being released
were not included in the recall.
These products are used under the care of a healthcare
professional and require a medical referral. Patients, caregivers
and healthcare professionals in need of these products should
contact Abbott at +1-800-881-0876 to provide necessary information.
Abbott will work with metabolic centers and healthcare providers to
fulfill requests based on need and on a case-by-case basis.
The metabolic products being released are:
- Calcilo XD®
- Cyclinex®-1 and 2
- Glutarex®-1 and 2
- Hominex®-1 and 2
- I-Valex®-1 and 2
- Ketonex®-1 and 2
- Phenex®-1 and 2
- Pro-Phree®
- Propimex®-1 and 2
- ProViMin®
- Tyrex®-1 and 2
The specialty product being released is:
Similac®, Alimentum® and
EleCare® powder formulas that were voluntarily recalled
in February are not included in this product release.
Abbott has limited inventory of these products. New product is
not currently being manufactured. Abbott has implemented corrective
actions and is working with the FDA to address the situation before
resuming operations at the Sturgis facility. Once Abbott resumes
production, it will take at least six to eight weeks for product to
be available for distribution.
No Link Between Sturgis
Facility and Reported Cases
On Feb. 17, 2022, Abbott issued a voluntary recall
of some powder infant formula products manufactured at its Sturgis
facility. The recall did not include any of Abbott's metabolic
nutrition formulas, and included only a single batch of Similac
PM 60/40. During the investigation, the metabolic nutrition
formulas and all other batches of Similac PM 60/40 were placed on
hold.
Abbott tests products prior to distribution, and no Abbott
formula distributed to consumers tested positive for Cronobacter
sakazakii or Salmonella. All finished product testing by
Abbott and the FDA during the inspection of the facility likewise
came back negative for Cronobacter sakazakii and/or
Salmonella. No Salmonella was found at the
Sturgis facility during the investigation. The Cronobacter
sakazakii 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.
A thorough review of all available data indicates that the
infant formula produced at our Sturgis facility is not likely the
source of infection in the reported cases and that there was not an
outbreak caused by products from the facility.
"We know this situation has worsened the industry-wide infant
formula supply shortage and we regret the anxiety and stress this
is causing," said Joe Manning,
executive vice president, nutritional products, Abbott. "Abbott is
committed to working with the FDA to address this situation so we
can resume operations at this facility and continue serving the
nutritional needs of people who rely on our infant and specialty
formulas."
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