Abbott Nutrition’s baby formula recall has been expanded to include one lot of Similac PM 60/40.
The Food and Drug Administration said in an update Monday that health officials were investigating an additional illness of Cronobacter sakazakii with exposure to powdered infant formula produced at the company’s Sturgis, Michigan facility. That baby also died of Cronobacter.
“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 FDA said.
Similac PM is considered “a specialty formula for certain infants who would benefit from lowered mineral intake.” It was not included in the previous recall for select lots of Similac, Alimentum and EleCare formulas announced Feb. 17.
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The previously recalled formulas were also produced at the Michigan facility. The lot of Similac PM 60/40 was distributed to the U.S. and Israel.
Cronobacter bacteria can cause severe, life-threatening sepsis infections or meningitis while Salmonella can cause gastrointestinal illness and fever, according to the FDA.
Abbott said in an update Monday that in addition to the other formula recalled it was recalling Lot # 27032K80 (can) / Lot # 27032K800 (case) of Similac PM 60/40 after learning of the baby’s death.
“This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined,” Abbott posted on its recall website. “We want to extend our heartfelt sympathies to the family.”
Abbott also said “no distributed product has tested positive for the presence of Cronobacter sakazakii” and recently tested retained product samples of Similac PM “were negative for Cronobacter.”
The FDA said its investigation with the Centers for Disease Control and Prevention now includes four reports of Cronobacter sakazakii infections in infants and one complaint of a Salmonella Newport infection. All of the babies were hospitalized and Cronobacter may have contributed to death in two patients.
The agency said it is “working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands.” The FDA said it is working with Abbott “on safe resumption of production at the Sturgis, MI facility.”
Similac recall 2022: What Abbott products have been recalled?
Abbott is voluntarily recalling one lot of Similac PM 60/40 Lot # 27032K80 (can) / Lot # 27032K800 (case).
Other products previously recalled include Similac, Alimentum and EleCare powdered infant formulas. Check a multidigit number on the bottom of the container to know if your product is included:
- 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.
More information is available at Similacrecall.com where you can type in the code on the bottom of the package. You can also call 1-800-986-8540 and follow the instructions provided.
According to Abbott, no liquid formulas, powder formulas or nutrition products from other facilities are impacted by the recall. The recalled products were only manufactured in Sturgis, Michigan, the company said.
What is Cronobacter sakazakii and how can it spread?
According to the CDC, Cronobacter sakazakii is a germ found naturally in the environment and can live in very dry places. The germs can live in dry foods, such as powdered infant formula, powdered milk, herbal teas and starches. It also has been found in wastewater.
Cronobacter illnesses are rare – the CDC said it typically receives reports of two to four infections in infants each year – but they are frequently lethal for infants and can be serious among people with immunocompromising conditions and the elderly. Only Minnesota requires reporting the illness.
In infants, Cronobacter usually causes sepsis or severe meningitis. Some infants may experience seizures. The mortality rate for Cronobacter meningitis may be as high as 40%, the CDC said.
Cronobacter can also cause wound infections or urinary tract infections in people of all ages.
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