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Class II · ModerateRecall completed

Acetaminophen Oral Solution

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

Does this affect you?
Check your lot numberLot: 20040A, EXP May 2022
Where it was soldDistributed in Indiana for further distribution 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: Failure to properly investigate failed microbial testing.

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

Distributed by / forMajor Pharmaceuticals, Livonia, MI 48152
NDC0904-6820-76
Show the full FDA record
Full product labelAcetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
Recalling firmPlastikon Healthcare LLC
DistributionDistributed in Indiana for further distribution in the USA.
Quantity121,800 Unit Dose cups
Recall initiated2022-03-24
Report date2022-05-25
Recall completed—
Recall numberD-0869-2022
ClassificationClass II
FDA statusCompleted
Origin on fileLawrence KS United States

Related

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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.