Abbott Voluntarily EXPANDS Recall of Powder Formulas Manufactured at One Plant - 3/10/22
Company Announcement Date:
February 28, 2022
FDA Publish Date:
March 07, 2022
Food & Beverages
Reason for Announcement:
Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport
Similac, Alimentum, and EleCare
Powder Infant Formula
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.
* We believe that none of the product being recalled were processed or offered through the national office
* We strongly encourage you to notify your agencies within one business day from receipt of this notice.
* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.
* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.
About Feeding America Recall Notices
The Feeding America national office issues notifications of all national Class I and II recalls–those involving a health hazard situation in which there is reasonable probability that eating the food will cause health problems or death–and other recalls that may affect the safety of food supplied to network members.
The national office strongly encourages all member product solicitors, operations managers, and others involved in food and grocery distribution to regularly consult resources provided by the United States Food and Drug Administration (FDA) at http://www.fda.gov/opacom/7alerts.html, and the United States Department of Agriculture (USDA) at http://www.fsis.usda.gov/Fsis_Recalls/index.asp. Additionally, members can often receive information on national, state, and local recalls by contacting their local health departments.
Feeding America National Office
35 E. Wacker Drive, Suite 2000
Chicago, IL 60601