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Alembic Pharmaceuticals Limited recall (Cls II)

August 13, 2025updated 5mo ago
community read0 votes

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

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same company · ±60 days · 5

  • approvalcarbamazepine ER: CARBAMAZEPINE — FDA approvalJul 25, 2025
  • approvalPAROXETINE HYDROCHLORIDE: PAROXETINE HYDROCHLORIDE — FDA approvalSep 24, 2025
  • approvalTIZANIDINE HYDROCHLORIDE: TIZANIDINE HYDROCHLORIDE — FDA approvalSep 24, 2025
  • approvalDESIPRAMINE HYDROCHLORIDE: DESIPRAMINE HYDROCHLORIDE — FDA approvalSep 29, 2025
  • recallAlembic Pharmaceuticals Limited recall (Cls II)Jun 18, 2025

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