FDA Expands Recall of Abbott Child Formulation

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March 1, 2022

The U.S. Meals and Drug Administration expanded its recall of Abbott child system after a second toddler turned sick with a bacterial an infection and died after consuming system.

The latest recall is for Similac PM 60/40 system, a specialty system for infants who want lowered mineral consumption, the FDA mentioned in a Monday information launch. It comes from the identical Sturgis, MI., manufacturing facility the place different recalled formulation have been made, the FDA mentioned.

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Within the newest case, the child who consumed Similac PM 60/40 system turned contaminated with Cronobactersakazakii and died, the FDA mentioned, noting that the an infection “might have been a contributing reason behind dying for this affected person.” Particulars concerning the location and date of the dying weren’t launched.

“At the moment, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the one kind and plenty of this specialty system being recalled,” the FDA mentioned.

​​“This case is underneath investigation, and at the moment the reason for the toddler’s Cronobacter sakazakii an infection has not been decided,” Abbott mentioned on its web site. “We wish to prolong our heartfelt sympathies to the household.”

Abbott mentioned no distributed product has examined optimistic for the presence of Cronobacter sakazakii and lately examined product samples of Similac PM 60/40 from the designated lot numbers have been detrimental for the micro organism.

With the most recent case, a complete of 5 infants are identified to have gotten sick and two have died after consuming Abbott system.

In mid-February, the FDA mentioned mother and father ought to cease utilizing three powdered child formulation — Similac, Alimentum, and EleCare — that have been made on the Sturgis manufacturing facility that have been linked to studies of bacterial infections in infants.

For the sooner recall, the FDA mentioned system shouldn’t be used if all three of those circumstances are met: the primary two digits of the product code are 22 by way of 37; the code on the container comprises K8, SH, or Z2; and the expiration date is April 1, 2022, or later.

To seek out out in case your system has been recalled, go to this web site and enter the product code on the underside of the bundle.

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