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.
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.
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.
Parents seeking the product should contact Abbott directly to request it, the FDA said.
Quoted from Various Sources
Published for: WATPFC