The FDA said that the U.S. CDC announced one additional illness of Cronobacter sakazakii (a type of bacteria) with exposure to powdered infant formula produced at Abbott (ABT) Nutrition's Sturgis, Michigan facility.
The agency said Cronobacter infection may have been a contributing cause of death for this patient.
On Feb. 17, Abbot began a voluntary recall of powder formulas, including Similac, Alimentum and EleCare manufactured in Sturgis, Michigan facility.
The FDA said the most recent patient was reported to have consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800 prior to Cronobacter sakazakiiI infection.
The FDA and CDC informed the company and on Feb. 28, Abbott Nutrition voluntarily recalled Similac PM 60/40 powdered infant formula with the lot code 27032K800.
The agency said this product was not included in the previous recall.
Currently, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled.
In Total, the FDA investigation includes four reports of Cronobacter sakazakii infections in infants (three from FDA complaints and one from a CDC case finding) and one complaint of a Salmonella Newport infection in an infant.
The FDA said all five (four Cronobacter infections and one Salmonella Newport infection) illnesses resulted in hospitalization and Cronobacter may have contributed to death in two patients.