The Food and Drug Administration has given permission to Abbott to partially restart its shuttered plant to help alleviate a shortage of baby formula nationwide and ship some of its previously produced products.
The FDA is allowing Abbott to release certain types of already-produced baby formula on a case-by-case basis to help alleviate the supply shortages that have impacted more than half of the country.
“The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products,” the FDA said Wednesday.
“In these circumstances, the benefit of allowing parents, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA added.
The baby formula that will be allowed to be released after it is tested are the specialty and metabolic varieties including:
- Phenex-2 Vanilla
- Calcilo XD
- Similac PM 60/40
Certain baby formulas produced at the Abbott Nutrition plant in Sturgis, Michigan, were recalled after four babies got sick after eating the powdered infant formula.
Two babies died.
The babies had rare infections caused by Cronobacter sakazakii, CNN reported.
Abbott said there was no evidence to link the recalled formulas to the baby’s illnesses and deaths, adding that the genetic sequencing of samples from two of the sick children did not match the same strain of the bacteria found at the plant, Market Watch reported.
Only the above-listed formulas will be approved to be released on a case-by-case basis, and “depending on product availability and the severity of the individual’s need,” the FDA said in the announcement.
Parents and caregivers are being instructed to contact Abbott directly to request the products. The number to call is 800-881-0876. However, before calling and requesting the products, the FDA is instructing parents to call their child’s health care provider to consider alternatives or if the risk should be taken, since the products were made during the time that the FDA investigated the plant.
The FDA had found that the company did not maintain sanitary conditions and follow procedures earlier this year, The Associated Press reported.
Despite the release of certain varieties of formula, the recalled brands should not be used.
They have 22 through 37 as the first two digits in the code printed on the container. The same code contains K8, SH or Z2 and has an expiration date of “4-1-2022″ (APR 2022) or later, the FDA said.
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