Abbott Issues Voluntarily Recalls of Some Powder Formulas

Date: 2022-Mar-02 Source:Dairy Reporter View: 1671

The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness related to products from Abbott Nutrition's Sturgis, Ml facility received from 9/20/2021 to 1/11/2022.

All cases are reported to have consumed powdered infant formula produced from Abbott Nutrition's Sturgis, Ml facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants.

The FDA said all four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case. The cases were in Minnesota, Ohio, and two in Texas.

The FDA has initiated an on site in spection at the facility. Findings to date include several positive Cronobacter results from environ mental samples taken by FDA, and adverse inspectional observations by FDA investigators. A review of the firm's internal records also indicate environmental contamination with C. sakazakii and the firm's destruction of product due to the presenee of Cronobacter.

On February 17, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the US and were likely exported to other countries as well. Canadian health officials have also issued a recall warning.

The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package. Products are included in the recall if all of these conditions are met: the first two digits of the code are 22 through 37 and the code on the container contains K8, SH, or Z2, and the expiration date is 4-1-2022 (APR 2022) or later.

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The recall does not include liquid formula products or any metabolic deficiency nutrition formulas.

Abbott said its recall does not include any metabolic deficiency nutrition formulas.

As part of Abbott's quality processes, the company said it conducts routine testing for C. sakazakii and other pathogens in its manufacturing facilities. During testing in the Sturgis, Mich., facility, Abbott said it found evidence of C. sakazakii in the plant in non-product contact areas, but found no evide nee of Salm on ella Newport. The investigation is on going.

While Chinese authorities said the affected formula products were not offered directly in China, China Customs has advised anyone who purchased them through cross-border e-commerce should stop using them. The GACC said it will continue to closely follow the FDA's investigation on the matter and keep consumers updated of any progress. Authorities in Singapore, Saudi Arabia, Oman and Bahrain have issued similar warnings.

Source: Dairy Reporter

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