The formula recalls have exacerbated product shortages due to supply chain issues.
As enhanced testing will take time, the FDA said it “has no objection” for Abbott to immediately release products to “individuals needing urgent, life-sustaining supplies” of certain specialty and metabolic formulas on a case-by-case basis.
“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 agency said. “In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.”
The FDA stressed that products produced at the facility from late January through early March, prior to an FDA inspection, may carry a risk of contamination, and said parents seeking the formula should talk to their child’s doctor about whether the benefit of consuming the formula outweighs the risk of a bacterial infection in their child’s circumstances.
In a Friday statement, Abbott said it “is releasing limited quantities of metabolic nutrition formulas at the request of FDA 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.”
Parents seeking the product should contact Abbott directly to request it, the FDA said. The company said products will be released free to patients, in coordination with healthcare professionals.
“We understand that every patient who relies on these important products has critical needs and we’re working diligently to get product to as many patients as possible,” the statement said.
The specialty and metabolic formulas that may be released on a case-by-case basis are the following: 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 formulas recalled earlier this year have been linked to serious Cronobacter sakazakii and Salmonella infections in five infants. Two of the babies with Cronobacter infections died.
No formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella, the Abbott statement said, and testing of retained products by Abbott and FDA for Cronobacter sakazakii and/or Salmonella all came back negative. The company also said no Salmonella was found at the facility during the investigation, and the Cronobacter sakazakii that was found was in non-product areas 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,” Abbott’s statement said.