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Recall Observatory FDA recall evidence

Drug product

Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-679-60

D-0330-2025

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-0330-2025

Official wording

Reason: CGMP Deviations

Code information: Lot # 17232533, exp. date Nov-25 17232534, exp. date Nov-25 17240606, exp. date Mar-26 17240619, exp. date Mar-26 17240911, exp. date May-26 17240912, exp. date May-26 17241121, exp. date Jun-26 17241124, exp. date Jun-26

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations