Class II
Ongoing
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
This recall is currently active, issued August 13, 2025. It was issued by Alembic Pharmaceuticals Limited.
- Company
- Alembic Pharmaceuticals Limited
- Recall Initiated
- July 25, 2025
- Posted
- August 13, 2025
- Recall Number
- D-0566-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,492 bottles
- Firm Location
- Panchmahal, India
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot: 2305015142, Exp. Date: 9/30/2025
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