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Class II · ModerateRecall completed

Acetaminophen And Codeine Phosphate

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

Does this affect you?
Check your lot numberLot #: 059180023A, 059180024A and 059180025A, Exp. Date 05/2021
Where it was soldNationwide within the United States
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 in a processing area in which water leakage was observed

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 byAurolife Pharma, LLC
Brand nameACETAMINOPHEN AND CODEINE PHOSPHATE
Generic nameACETAMINOPHEN AND CODEINE PHOSPHATE
Active ingredient(s)ACETAMINOPHEN, CODEINE PHOSPHATE
Distributed by / forAurobindo Pharma USA, Inc., Dayton, NJ 08810
NDC13107-059-99
Show the full FDA record
Full product labelAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide within the United States
Quantity4332 units
Recall initiated2020-03-18
Report date2020-04-22
Recall completed2024-03-25
Recall numberD-1230-2020
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ 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.