The report of an additional death in an outbreak linked to powdered infant formula has resulted in an expansion of a recall by Abbott Nutrition.
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 sakazakii infection.
The Food and Drug Administration and the Centers for Disease Control and Prevention informed the company of these findings and today Abbott Nutrition voluntarily recalled the implicated Similac product.
"This is a specialty formula for certain infants who would benefit from lowered mineral intake and was not included in the previous recall. At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled," according to an outbreak update from the FDA.
The CDC reported that the additional illness of Cronobacter sakazakii is linked to powdered infant formula produced at Abbott Nutrition's Sturgis, MI, facility. Cronobacter infection may have been a contributing cause of death for this patient, according to the agency.
In total, the U.S. outbreak 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. All five illnesses have resulted in hospitalization.
At least three reports of sick babies have been reported in the United Kingdom in relation to infant formula included in Abbott's initial recall.
"All of the ill patients (in the U.S.) are reported to have consumed powdered infant formula produced from Abbott Nutrition's Sturgis, MI, facility," according to the FDA.
Abbott representatives have said that none of the company's product has tested positive for either of the bacteria cited in the current outbreak. However, the FDA investigation has discovered Cronobacter in the implicated production facility. The FDA investigators also found internal Abbott documentation that product has tested positive for Cronobacter in the past, resulting in the destruction of infant formula produced at the Sturgis, MI, factory.
The FDA has reported that contamination in production facilities can easily contaminate infant formula.
Production at the Abbott factory in Sturgis, MI, has been halted while the FDA and the company investigate the situation.
Source: Food Safety News
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