FDA-Drug2025-04-16Class II

Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60

Glenmark Pharmaceuticals Inc., USA
Hazard

CGMP Deviations

Sold states
U.S. Nationwide
Affected count
N/A
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2025

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