https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-expands-recall-powder-formulas-manufactured-one-plant
Abbott Voluntarily Expands Recall of Powder Formulas Manufactured at One Plant
Summary
Company Announcement Date: February 28, 2022
FDA Publish Date: March 07, 2022
Product Type: Food & Beverages
Reason for Announcement: Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport
Company Name: Abbott
Brand Name: Similac, Alimentum, and EleCare
Product Description: Powder Infant Formula
Company Announcement
02.28.2022 EXPANDED: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. This is in addition to lots of Similac®, Alimentum® and EleCare® powder formula that were voluntarily recalled on Feb. 17. The action comes after learning of the death of an infant who tested positive for Cronobacter sakazakii and who we were informed had consumed Similac PM 60/40 from this lot. This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined. We want to extend our heartfelt sympathies to the family.
Importantly, no distributed product has tested positive for the presence of Cronobacter sakazakii. Additionally, recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative for Cronobacter.
02.28.2022 EXPANDED: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. This is in addition to lots of Similac®, Alimentum® and EleCare® powder formula that were voluntarily recalled on Feb. 17. The action comes after learning of the death of an infant who tested positive for Cronobacter sakazakii and who we were informed had consumed Similac PM 60/40 from this lot. This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined. We want to extend our heartfelt sympathies to the family.
Importantly, no distributed product has tested positive for the presence of Cronobacter sakazakii. Additionally, recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative for Cronobacter.
02.17.2022 Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan, one of the company’s manufacturing facilities. The recall does not include any metabolic deficiency nutrition formulas.
Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.
Additionally, as part of Abbott's quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogens in our manufacturing facilities. During testing in our Sturgis, Michigan, facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.
Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. All finished infant formula powder products are tested for Cronobacter, Salmonella, and other pathogens, and they must test negative before the product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella.
While Abbott's testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. No Abbott liquid formulas are included in the recall, nor are powder formulas or nutrition products from other facilities.
If your infant is experiencing symptoms related to Cronobacter or Salmonella infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care.
To find out if the product you have is included in this recall, click on the button below to check your lot number.
Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.
Additionally, as part of Abbott's quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogens in our manufacturing facilities. During testing in our Sturgis, Michigan, facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.
Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. All finished infant formula powder products are tested for Cronobacter, Salmonella, and other pathogens, and they must test negative before the product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella.
While Abbott's testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. No Abbott liquid formulas are included in the recall, nor are powder formulas or nutrition products from other facilities.
If your infant is experiencing symptoms related to Cronobacter or Salmonella infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care.
To find out if the product you have is included in this recall, click on the button below to check your lot number.
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