By Miriam Raftery
Photo: CC by SA via Bing
February 19, 2022 (Washington D.C.0 – The U.S. Food and Drug Administration (FDA) is warning consumers not to use recalled powdered infant formulas sold under the brand names Similac, Alimentum and EleCare in the U.S. and other countries.
The recall was triggered by four cases 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, according to the FDA.
All were produced at Abbott Nutrition’s Sturgis, Michigan facility. An inspector found Cronobacter and adverse conditions at the site. The recall includes only powdered formulas, not liquid 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 they have all three items below:
- 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.
If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
If your child is experiencing any of these symptoms, you should notify your child’s healthcare provider and seek medical care for your child immediately. Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to CDC.
This is an ongoing investigation and the firm is working with the FDA to initiate a voluntary recall of potentially affected product. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available.
To report a complaint or adverse event (illness or serious allergic reaction), you can:
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.