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Class II · ModerateRecall completed

Childrens Pain And Fever

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch: 1BK1045, Exp 12/31/2022
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byKroger Company
Brand nameCHILDRENS PAIN AND FEVER
Generic nameACETAMINOPHEN
Active ingredient(s)ACETAMINOPHEN
Distributed by / forTHE KROGER CO., CINCINNATI, OHIO 45202
NDC30142-818-26
Show the full FDA record
Full product labelAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-26
Recalling firmPerrigo Company PLC
DistributionNationwide in the USA
Quantity20,448 bottles
Recall initiated2021-10-26
Report date2022-03-02
Recall completed2023-09-29
Recall numberD-0588-2022
ClassificationClass II
FDA statusTerminated
Origin on fileAllegan MI United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.