Formula recalls have exacerbated product shortages due to supply chain issues.
Because enhanced testing would take time, the FDA said it had “no objection” to Abbott releasing products immediately “for individuals who need an urgent, life-sustaining supply” of certain specialized and metabolic formulas on a case-by-case basis.
“The FDA is concerned that the risk of unavailability of certain specialty and metabolic products could significantly worsen underlying medical conditions and, in some cases, pose life-threatening risks to infants and individuals who depend on these products,” the agency said. “In these circumstances, the benefit of allowing parents, in consultation with health care providers, access to these products may outweigh the potential risks of bacterial infection.”
The FDA stressed that products produced at the facility from late January through early March, prior to FDA examination, may carry a risk of contamination, and said parents looking for formula should speak to their child’s doctor about whether it’s a benefit to consume The formula outweighs the risk of bacterial infection in their children’s circumstances.
Formulas recalled earlier this year have been linked to serious infections of Cronobacter sakazakii and Salmonella bacteria in five children. Two children with Cronobacter infection died.
The specialized and metabolic formulas that can be released on a case-by-case basis are as follows: 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 FDA said that parents seeking the product should contact Abbott directly to order it.