They are related to products from Abbott Nutrition’s Sturgis, MI facility received from 9/20/2021 to 1/11/2022.
All of the cases are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case.
FDA has initiated an onsite inspection at the facility.
Findings to date include several positive Cronobacter results from environmental samples taken by FDA, and adverse inspectional observations by FDA investigators.
A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.
FDA is issuing this advisory to alert consumers to avoid purchasing or using recalled powdered infant formula produced in the Sturgis, MI facility.
On 2/17/2022, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the United States and were likely exported to other countries as well.
Canadian health officials have also issued a recall warningExternal Link Disclaimer. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available.
"Abbott (NYSE: ABT) is initiating a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare manufactured in Sturgis, Mich., one of the company's manufacturing facilities. The recall does not include any metabolic deficiency nutrition formulas", Abbott said.
"Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.
"Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release.
"All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport.
"While Abbott's testing of finished product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. No Abbott liquid formulas, powder formulas, or nutrition products from other facilities are impacted by the recall.
"The products under recall have a multidigit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after." ■