Abbott plans to restart plant at the heart of the baby formula recall on June 4
May 25, 2022, 9:03 AM | Updated: Jun 8, 2022, 3:14 pm
(CNN) — Abbott Nutrition said Tuesday that it plans to restart work at the Sturgis, Michigan, plant at the heart of the nationwide baby formula recall on June 4, with the first batches of new formula expected to be available to consumers on or around June 20.
When the plant resumes manufacturing formula, the company confirmed to the U.S. Food and Drug Administration, it will start with EleCare and other specialty metabolic formulas.
Abbott will also release about 300,000 cans of EleCare Specialty Formula on a case-by-case basis to people who need it urgently. This is an amino acid-based hypoallergenic product for babies who can’t tolerate cow’s milk in other formulas due to an intolerance or allergy.
This formula was not a part of the company’s recall earlier in the year, but it has been on hold at the Sturgis plant because the agency was concerned that it was produced under “insanitary conditions.” The FDA said the formula will undergo enhanced testing to make sure it is safe.
The formula will be available immediately at no charge. Parents and caregivers can ask their doctors for more information or call Abbott at 1-800-881-0876.
Similac and Alimentum powder formulas that were recalled in February are not included in the product release, Abbott said.
Abbott’s Sturgis plant shut down in February. During inspections that spanned January, February and March, FDA investigators found Cronobacter sakazakii bacteria in several areas inside the plant.
In May, a federal judge signed off on a consent decree that laid out the steps the company needed to take to restart production. Abbott said at the time that once it completed those steps, it would take about two weeks to restart production.
Under the consent decree, the company will also keep an independent expert on site to review operations and to make sure the plant is in compliance with FDA rules.
The FDA said Tuesday that it is doing “everything in our power” to make sure there is enough baby formula for parents and caregivers who need it.
The agency is allowing Kendal Nutricare, a company based in the U.K., to import some of its baby formula to the U.S., and 2 million cans will be on U.S. store shelves starting in June. The government is working with the company to fast-track its efforts to immediately send more than 40,000 cans that are now in stock.
Before taking these steps, the FDA had to evaluate the nutritional quality of Kendal’s product and the tests the company has done to show that it is safe, as well as its production and inspection history.
The FDA says it is in discussions with other manufacturers and suppliers about bringing other baby formulas to the US.
“Our recent steps will help further bolster supply of infant formula, including through the import of safe and nutritious products from oversees based on our increased flexibilities announced last week,” FDA Commissioner Dr. Robert Califf said in a news release. “Importantly, we anticipate additional infant formula products may be safely and quickly imported into the U.S. in the near-term based on ongoing discussions with manufacturers and suppliers worldwide.”
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