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Class II · ModerateRecall completed

Hydrocodone Bitartrate And Acetaminophen

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

Does this affect you?
Check your lot numberLot #: 21070817, Exp 6/2023
Where it was soldUSA Nationwide
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

Product Mix-up

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 byAscent Pharmaceuticals, Inc., Central Islip, NY 11722
Brand nameHYDROCODONE BITARTRATE AND ACETAMINOPHEN
Generic nameHYDROCODONE BITARTRATE AND ACETAMINOPHEN
Active ingredient(s)ACETAMINOPHEN, HYDROCODONE BITARTRATE
Distributed by / forCamber Pharmaceuticals, Inc. Piscataway, NJ 08854
NDC31722-997-01
Show the full FDA record
Full product labelHydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.
Recalling firmAscent Pharmaceuticals, Inc.
DistributionUSA Nationwide
Quantity9744 bottles
Recall initiated2021-11-19
Report date2021-12-15
Recall completed2023-12-06
Recall numberD-0276-2022
ClassificationClass II
FDA statusTerminated
Origin on fileCentral Islip NY 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.