Recalls / Class II
Class IID-0276-2022
Product
Hydrocodone 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.
- Brand name
- Hydrocodone Bitartrate And Acetaminophen
- Generic name
- Hydrocodone Bitartrate And Acetaminophen
- Active ingredients
- Acetaminophen, Hydrocodone Bitartrate
- Route
- Oral
- NDCs
- 31722-996, 31722-997
- FDA application
- ANDA211487
- Affected lot / code info
- Lot #: 21070817, Exp 6/2023
Why it was recalled
Product Mix-up
Recalling firm
- Firm
- Ascent Pharmaceuticals, Inc.
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 S Technology Dr, N/A, Central Islip, New York 11722-4402
Distribution
- Quantity
- 9744 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-11-19
- FDA classified
- 2021-12-07
- Posted by FDA
- 2021-12-15
- Terminated
- 2023-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0276-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.