Recalls / Class II
Class IID-0097-2021
Product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01
- Affected lot / code info
- Lot #: 20070518, Exp. Date June 2022
Why it was recalled
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Recalling firm
- Firm
- Ascent Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 S Technology Dr, N/A, Central Islip, New York 11722-4402
Distribution
- Quantity
- 9768 Bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-10-26
- FDA classified
- 2020-11-17
- Posted by FDA
- 2020-11-25
- Terminated
- 2023-02-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0097-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.