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  5. Public Alert No: 008/2022 – Class I Recall: Abbott Recalls Certain Powdered Infant Formula Linked…

Public Alert No: 008/2022 – Class I Recall: Abbott Recalls Certain Powdered Infant Formula Linked To Food Borne Illness Outbreak Due To Presence Of Cronobacter Sakazakii And Salmonella Newport Bacteria

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In the U.S, four consumer complaints of infant illness were received from September 2021 to December 2021. This includes three reports of Cronobacter sakazakii infections and one Salmonella Newport infection. All four infants were hospitalized and Cronobacter may have contributed to one death.

Abbott’s recall of these powdered  infant formula produced at its facility in Sturgis, Michigan MI, has spread globally and now includes Croatia, Italy, Ireland, Netherlands, Slovenia, and Spain, among many other countries. Food Standards Agency (FSA) is investigating whether three infant illnesses reported recently  in the United Kingdom are connected to an outbreak in the United States from the recalled  infant formula.

Background:

Cronobacter bacteria can cause severe, life-threatening infections(sepsis) or meningitis. Symptoms of which include poor feeding, irritability, temperature changes, jaundice, grunting breaths and abnormal movement in infants. The infection can also lead to bowel damage and may spread through the blood to other parts of the body.

Salmonella bacteria causes gastrointestinal illness, fever called salmonellosis which may lead to diarrhea, fever, and abdominal cramps. A severe case of salmonella infection results in headache, lethargy, rash, blood in the urine or stool and may be fatal in some cases.

Details of Recalled Products:

Brand Product Size UPC Codes
Abbott

Sturgis, MI

Similac Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder 658 g 0 55325 00076 1 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder 964 g 0 55325 00163 8 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder 658 g 0 55325 00077 8 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder 964 g 0 55325 00164 5 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Alimentum Step 1 Hypoallergenic Infant Formula Powder 400 g 0 55325 00061 7 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Human Milk Fortifier Powder 50 x 0.90 g 0 55325 54598 9 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder 227 g 0 55325 00260 4 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder 584 g 0 55325 00281 9 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder 658 g 0 55325 00249 9 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder 859 g 0 55325 00283 3 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Brand Product Size UPC Codes
Abbott

Sturgis MI

Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder 964 g 0 55325 00254 3 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Pro-Advance Step 1 Milk-Based Iron-Fortified Infant Formula Powder 1134 g 0 55325 00306 9 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Pro-Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder 584 g 0 55325 00286 4 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Pro-Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder 658 g 0 55325 00256 7 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Pro-Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder 859 g 0 55325 00288 8 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Pro-Advance Step 2 Milk-Based Iron-Fortified and Calcium-Enriched Infant Formula Powder 964 g 0 55325 00258 1 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Sensitive (Lactose Sensitivity) Step 1 Milk-Based Iron-Fortified Infant Formula Powder 638 g 0 55325 00121 8 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Total Comfort Step 1 Milk-Based Iron-Fortified Infant Formula Powder 227 g 0 55325 62662 6 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Total Comfort Step 1 Milk-Based Iron-Fortified Infant Formula Powder 638 g 0 55325 62660 2 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Abbott

Sturgis MI

Similac Total Comfort Step 1 Milk-Based Iron-Fortified Infant Formula Powder 964 g 0 55325 00165 2 All lot codes where:

– The first 2 digits range from 22 through to 37;

AND

– Contain K8, SH, or Z2;

AND

– Have an expiration date of 1APR2022 or after

Product Images:


Batch coding detail of the recalled product is shown above

PLEASE NOTE THAT ABBOTT’S SIMILAC INFANT FORMULA POWDER REGISTERED BY NAFDAC ARE MANUFACTURED IN SOUTH AFRICA AND REPUBLIC OF IRELAND WHILE,

THE RECALLED PRODUCTS LISTED ABOVE WERE MANUFACTURED IN STURGIS, MICHIGAN- AMERICA.

Recommendation:

The Agency advises that parents of infant experiencing any of these symptoms after consumption of the recalled Abbott Infant formula, should notify your child’s healthcare provider and seek medical care for your child immediately.  Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to relevant authorities.

NAFDAC implores importers, distributors, retailers and the public to exercise caution and vigilance to avoid  sale, distribution and consumption  of the recalled  products listed above or if in possession should  submit  to the nearest NAFDAC office or report to NAFDAC PRASCOR (20543 or 0800-1-623322) TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or via e-Reporting platform available on the NAFDAC website www.nafdac,gov.ng.

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

Signed Management

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