The FDA and the US Centers for Disease Control and Prevention are currently reviewing Abbott Nutrition’s powdered infant formula products. Abbott has recalled and withheld Similac, Alimentum and EleCare products manufactured at its Sturgis, Michigan facility while extended safety testing is conducted.
The formula recalls have exacerbated product shortages due to supply chain issues.
Because expanded testing will take time, the FDA said it has “no objection” to Abbott immediately clearing products on a case-by-case basis for “individuals who need urgent, life-sustaining care” of certain specialty and metabolic formulas.
“The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying conditions and, in some cases, pose life-threatening risks to infants and individuals who rely on these products,” the agency said . “In these circumstances, the benefit of giving parents access to these products, in consultation with their healthcare providers, may outweigh the potential risk of bacterial infection.”
The FDA stressed that products manufactured at the facility before an FDA inspection in late January through early March could pose a risk of contamination, and said parents seeking the formula should speak with their child’s doctor about whether the benefit of consuming the formula outweighs the risk of bacterial infection in your child’s circumstances.
In a statement Friday, Abbott said it is “releasing limited quantities of metabolic nutrition formulas at FDA request that were previously on hold after Abbott recalled some powdered infant formulas from its Sturgis, Michigan facility. Products have been tested and meet all product approval requirements prior to distribution. The released batches were not included in the recall.”
Parents seeking the product should contact Abbott directly to request it, the FDA said. The company said the products will be released to patients free of charge in coordination with healthcare professionals.
“We understand that every patient who relies on these important products has critical needs, and we are working diligently to make the product available to as many patients as possible,” the statement said.
The following special and metabolic formulas can be released on a case-by-case basis: Glutarex-1, Glutarex-2, Cyclinex-1, Cyclinex-2, Hominex-1, Hominex-2, I-Valex-1 , I-Valex-2, Ketonex -1, Ketonex-2, Phenex-1, Phenex-2, Phenex-2 Vanilla, Pro-Phree, Propimex-1, Propimex-2, ProViMin, Calcilo XD, Tyrex-1, Tyrex -2 and Similac PM 60/40 .
The formula, recalled earlier this year, has been linked to severe Cronobacter sakazakii and Salmonella infections in five infants. Two of the babies with Cronobacter infection died.
No formula distributed to consumers has tested positive for Cronobacter sakazakii or Salmonella, Abbott’s statement said, and testing of retained products by Abbott and the FDA for Cronobacter sakazakii and/or Salmonella was all negative. The company also said no salmonella was found at the facility during the investigation, and the Cronobacter sakazakii found was in non-product areas and was not linked to any known infant disease.
“A thorough review of all available data indicates that infant formula manufactured at our Sturgis facility is unlikely to be the source of infection in the reported cases and that there has been no outbreak caused by products from the facility,” the statement read Abbott.