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.
The newly implicated product, Similac PM 60/40, was distributed across the United States and in Israel. Previously recalled formula was distributed in dozens of countries.
“We understand that infant formula is the sole source of nutrition for many infants and is an essential product,” the FDA said in its outbreak update. “If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.”
The recalled powdered infant formula sold under the brands Similac, Alimentum, or EleCare 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 of these codes:
- 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.
Additional recall information for the initial recall is available on the FDA website. Parents can also enter their product lot code on the company’s website to check if it is part of the recall.
“The recalls do not include liquid formula products. Consumers should continue to use all product not included in the recalls,” according to the FDA.
“Parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants. Consumers should also avoid purchasing imported formula through online sales, as it has the potential to be counterfeit.”
Consumers who receive their infant formula through the WIC program should not throw the formula out. Instead, they should take it to the store for a refund and exchange or call the company at 800-986-8540 to help you. WIC recipients should be able to obtain a different brand of similar formula. Call your local WIC clinic for more guidance. Also see:
- USDA FNS (WIC) Infant Formula Safety
- Toll-Free Numbers for WIC State Agencies
- USDA Contact Map
More information on Cronobacter and infant formula is available on CDC’s website.
To report an illness or adverse event, consumers can
- Call an FDA Consumer Complaint Coordinator 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.
About cronobacter infections
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, 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.
About Salmonella infections
Food contaminated with Salmonella bacteria does not usually look, smell, or taste spoiled. Anyone can become sick with a Salmonella infection. Infants, children, seniors, and people with weakened immune systems are at higher risk of serious illness because their immune systems are fragile, according to the CDC.
Anyone who has used any of the recalled products and seen symptoms of Salmonella infection in their infants should seek medical attention. Parents and caregivers should tell doctors about the possible exposure to Salmonella bacteria because special tests are necessary to diagnose salmonellosis. Salmonella infection symptoms can mimic other illnesses, frequently leading to misdiagnosis.
Symptoms of Salmonella infection can include diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating contaminated food. Otherwise, healthy adults are usually sick for four to seven days. In some cases, however, diarrhea may be so severe that patients require hospitalization.
Older adults, children, pregnant women, and people with weakened immune systems, such as cancer patients, are more likely to develop a severe illness and serious, sometimes life-threatening conditions.
Some people get infected without getting sick or showing any symptoms. However, they may still spread the infections to others.
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