D-0566-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 13, 2025
- Initiation Date
- July 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,492 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: 2305015142, Exp. Date: 9/30/2025