Recall D-0566-2025

US Class II Ongoing · initiated 2025-07-25

Recalling firm

Alembic Pharmaceuticals Limited

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

Reason for recall

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

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