Glenmark Pharmaceuticals Inc., USA
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
CGMP Deviations
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
Lot # 17240221, exp. date Jan-26 17240222, exp. date Jan-26
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →