Drug 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
D-0097-2021
Product summary
- Event
- Event 86665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9768 Bottles
- Official record key
drug-enforcement:D-0097-2021
Official wording
Reason: 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.
Code information: Lot #: 20070518, Exp. Date June 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet