The United States Food and Drug Administration (FDA) declared that the agency had launched a new investigation into reports of Salmonella newborn infections associated with some lots of Abbott Nutrition Infant Formula. The FDA’s warning to consumers states that the affected infant formula was manufactured at Abbott Nutrition’s facility in Sturgis, Michigan. Several government agencies coordinate and handle this investigation, including the FDA, the U.S. Centers for Disease Control and Prevention, and Michigan agencies. The FDA is alerting consumers of the potential issue and is urging parents and caregivers to avoid purchasing or feeding infants with the affected powdered infant formula products. The Salmonella contamination investigation is ongoing, and Abbott Nutrition is working with the FDA. The company is initiating a recall of the potentially Salmonella-contaminated infant food products.
The FDA is warning consumers to immediately stop using EleCare, Alimentum, or Similac powdered infant formulas if:
- the expiration date is April 1, 2022, or later;
- the package code includes SH, Z2, or K8; and
- the code’s first two numbers have the numbers 22 through 37.
The FDA is also investigating the reports of four infant infections. In the four cases, the babies were hospitalized. Three of the cases involved Cronobacter Sakazakii infections, and the other case involved Salmonella. The FDA also launched an inspection of the Michigan manufacturing facility. Those inspection results include multiple Cronobacter sakazakii positive results on tests performed on environmental specimens gathered by FDA investigators. An examination of Abbott Nutrition’s internal corporate records also revealed Cronobacter Sakazakii environmental contamination and internal records of the company’s destruction of infant products contaminated with Cronobacter Sakazakii.
The FDA’s Deputy Commissioner for Food Policy and Response, Frank Yiannas, stated that the FDA is concerned about the report of bacterial infections, particularly since the products are the only source of nutrition for infants and newborns. Mr. Yiannas also stated that the FDA is working to resolve the safety issue as quickly as possible.
The impacted products made at the Sturgis manufacturing plant were delivered to retailers across the United States and could have been exported. The FDA warning announcement did not pertain to metabolic deficiency nutrition formulas or liquid infant formula products. According to the company, the newly recalled infant formula products were distributed to Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.
Salmonella is a form of bacteria that causes a fever called salmonellosis and gastrointestinal illnesses. People who have salmonellosis suffer symptoms, including fever, diarrhea, and abdominal cramps. Severe cases of salmonellosis can include aches, high fever, lethargy, headaches, rashes, blood in the stool or urine, and in severe cases, death. If your child experiences one or more of these symptoms, contact your child’s doctor and seek medical attention for your child immediately. Parents and caregivers shouldn’t dilute or make homemade infant formula. In the event that regular infant formula is unavailable, speak with your baby’s doctor for advice on changing your infant’s feeding practices.
The FDA is continuing its investigation into these infant formula products and will publish updated consumer safety information when available.
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