Drug recall D-0566-2025
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
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lots and codes
Lot: 2305015142, Exp. Date: 9/30/2025
Recall details
- Recalling firm
- Alembic Pharmaceuticals Limited, Panchmahal, N/A
- Quantity
- 9,492 bottles
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 25, 2025
Related products
- doxepin hydrochloride – drug information
- NDC 62332-637 Doxepin Hydrochloride · Doxepin Hydrochloride 10 mg/1 · Alembic Pharmaceuticals Inc.
- NDC 62332-640 Doxepin Hydrochloride · Doxepin Hydrochloride 100 mg/1 · Alembic Pharmaceuticals Inc.
- NDC 62332-639 Doxepin Hydrochloride · Doxepin Hydrochloride 75 mg/1 · Alembic Pharmaceuticals Inc.
- NDC 62332-645 Doxepin Hydrochloride · Doxepin Hydrochloride 50 mg/1 · Alembic Pharmaceuticals Inc.
- NDC 62332-638 Doxepin Hydrochloride · Doxepin Hydrochloride 25 mg/1 · Alembic Pharmaceuticals Inc.