FDARecalled Aug 13, 2025 · #D-0566-2025
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....
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Classification: Class II Distribution: Nationwide in the USA.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Alembic Pharmaceuticals Limited
- Model numbers
- 2305015142
- UPCs
- —