Status
Ongoing
Drug Enforcement D-0566-2025
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Classification
Class II
Report Date
August 13, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 9,492 bottles
- Reason for recall
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Recall initiation reason
- —
- Initial firm notification
- N/A
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Alembic Pharmaceuticals Limited
- Address
-
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, N/A
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0566-2025
- Event ID
- 97323
- Recall initiation date
- July 25, 2025
- Center classification date
- August 1, 2025
- Code info
- Lot: 2305015142, Exp. Date: 9/30/2025
- More code info
- —