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Recall Observatory FDA recall evidence

Drug product

Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01

D-0344-2025

March 13, 2025

Class II

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 96474
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0344-2025

Official wording

Reason: CGMP Deviations

Code information: Lot # 17241278, exp. date Jul-26 17241297, exp. date Jul-26 17241304, exp. date Jul-26 17241315, exp. date Jul-26 17241327, exp. date Jul-26

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations