Drug product
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
D-0566-2025
Product summary
- Event
- Event 97323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9,492 bottles
- Official record key
drug-enforcement:D-0566-2025
Official wording
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Code information: Lot: 2305015142, Exp. Date: 9/30/2025
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
Nitrosamine Drug Substance Related Impurity
-
Manufacturing or process control
CGMP Deviations