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Public Alert No.022/2022 – Abbott Voluntarily Expands Recall of Powder Formulas Similac PM 60/40 (Lot # 27032K80 (can) Manufactured at One Plant

April 1, 2022,

The National Agency for Food and Drug Administration and Control is notifying the public that Abbott (NYSE: ABT) is initiating a proactive, voluntary recall of powder formulas, including Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case), Alimentum and EleCare manufactured in Sturgis, Mich., 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. The action comes after learning of the death of an infant who tested positive for Cronobacter sakazakii and information at our disposal suggests the consumption of Similac 60/40 PM 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.

According to Abbott, no distributed product has tested positive for the presence of Cronobacter sakazakii. Recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative for Cronobacter. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport.

During Abbott routine testing in Sturgis, Michigan, facility, they found evidence of Cronobacter sakazaki in the plant in non-product contact areas and found no evidence of Salmonella in Newport. 

While Abbott’s testing of distributed product detected no pathogens, Abbots is acting 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

Cronobacter sakazakii is commonly found in the environment and a variety of areas in the home. It can cause fever, poor feeding, excessive crying, or low energy as well as other serious symptoms. It’s important to follow the instructions for proper preparation, handling and storage of powder formulas.

 Details of the product are given as Below:

Product Name Expiry Date Lot No Manufacturer Product description
Similac PM 60/40 April 1, 2022 PM 60/40 Lot # 27032K80 (can)

Lot #27032K800 (case)

Abbotts Nutrition.  Sturgis, Michigan

USA

 

The products under recall have a multidigit no on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after.

If any infant is experiencing any symptoms relating 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.

Members of the public already in possession of the above stated product batch are implored not to consume the product and handover stock to the nearest NAFDAC office.

Consumers are encouraged to report consumer complaints, adverse effects, side effects and related to the use of any regulated product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng  

References

www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-expands-recall-powder-formulas-manufacturer

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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