FDA Warns of Possible Bacterial Contamination in Nutramigen Infant Formula; Reckitt/Mead Johnson Initiates Recall

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ICARO Media Group
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31/12/2023 23h21

In a recent announcement by the US Food and Drug Administration (FDA) on Sunday, consumers were alerted to a potential bacterial contamination found in Reckitt/Mead Johnson's Nutramigen Hypoallergenic Powdered Infant Formula Products. This specialized formula is commonly used by infants who are allergic to cow's milk.

The FDA issued the warning after being notified by the Israeli Ministry of Health that exported Nutramigen formula tested positive for Cronobacter sakazakii, a bacterium known to cause rare but potentially fatal infections in newborns. As a result, Reckitt/Mead Johnson voluntarily recalled 675,030 cans of the formula on December 29. The recalled product had been distributed in the United States and additional quantities were exported.

It is important to note that no illnesses related to the contaminated formula have been reported thus far, and the FDA believes that a majority of the distributed product has likely been consumed already.

Reckitt/Mead Johnson assured consumers in a press release that the product in question had undergone extensive testing, all of which returned negative results for the bacteria.

Consumers who possess Nutramigen Hypoallergenic Infant Formula Powder with the specified batch codes are advised by the FDA to refrain from using the product and dispose of it immediately. Additionally, they may contact Reckitt/Mead Johnson Nutrition to obtain a refund.

While the Nutramigen formula is a specialty infant formula, the FDA recommends that users consult with their healthcare providers to find alternative products.

The concerning discovery of Cronobacter bacteria in the Nutramigen formula came to light on December 14 when the Israeli Ministry of Health notified the FDA about a positive test result during routine sampling at the Israeli border. In collaboration with the FDA, Israel conducted whole genome sequencing of the products, confirming the presence of the bacteria on December 28.

Reacting swiftly to the revelation, the FDA initiated an inspection at Reckitt/Mead Johnson Nutrition's Zeeland facility on December 18. The inspection included comprehensive testing of formula samples and environmental sampling. As of now, all tests conducted by the FDA have returned negative results for Cronobacter.

The FDA's inspection of Reckitt/Mead Johnson Nutrition's facility is currently ongoing, with their efforts aimed at ensuring the safety of infant formula products and preventing any potential harm to consumers.

The views expressed in this article do not reflect the opinion of ICARO, or any of its affiliates.

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