FDA-Drug2025-08-13Class II
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
Alembic Pharmaceuticals Limited
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Sold states
Nationwide in the USA.
Affected count
9,492 bottles
Manufactured in
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, N/A, Panchmahal, N/A, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0566-2025Don't want to check this manually?
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