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Class II · ModerateRecall completed

Oxycodone And Acetaminophen

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

Does this affect you?
Check your lot numberLot #: 046180056A, Exp. Date 05/2020
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 nameOXYCODONE AND ACETAMINOPHEN
Generic nameOXYCODONE AND ACETAMINOPHEN
Active ingredient(s)ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE
Distributed by / forAurobindo Pharma USA, Inc. Dayton, NJ 08810
NDC13107-046-01
Show the full FDA record
Full product labelOxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide within the United States
Quantity14707 units
Recall initiated2020-03-18
Report date2020-04-22
Recall completed2024-03-25
Recall numberD-1237-2020
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

Acetaminophen recallsRecent 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.