FDA is allowing Abbott Nutrition to immediately release some of the company’s infant formulas made at a plant being investigated for Cronobacter sakazakii contamination. The agency has cleared the company to supply specialty and metabolic formulas for individuals needing urgent, life-sustaining supplies 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. 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,” FDA said in a statement.
FDA, along with the Centers for Disease Control and Prevention and state and local partners, is investigating consumer complaints and/or reports of infant illness received from September 2021 to January 2022 related to products from Abbott Nutrition’s Sturgis, Mich., facility.
Following the voluntary recall and hold of certain powdered infant formulas produced at the facility, Abbott has committed to completing enhanced testing of stored product batches prior to making release determinations. While FDA said in a statement that it recognizes that Abbott has conducted standard product testing, the agency added that there were a limited number of samples tested. Additionally, although finished product testing does not eliminate the risk of contamination, the enhanced testing will provide for a greater chance to detect Cronobacter sakazakii, if present; however, this enhanced level of testing will take additional time.
Abbott has confirmed with FDA that the company will consider release of these infant formulas on a case-by-case basis, depending on product availability and the severity of the individual’s need. The specialty and metabolic formulas that may be released are:
- Phenex-2 Vanilla
- Calcilo XD
- Similac PM 60/40
Patients and caregivers seeking access to these products should contact Abbott Nutrition directly to request that a product be made available to them by calling 1-800-881-0876.