LACOSAMIDE Recall D-0343-2025
Description: Lacosamide Tablets 150mg, 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# 68462-680-60.
LACOSAMIDE Recall D-0343-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0343-2025 |
| Event ID | 96474 |
| Brand | LACOSAMIDE |
| Generic Name | LACOSAMIDE |
| Manufacturer | LACOSAMIDE |
| Original Package? | 1 |
| Active Substance | LACOSAMIDE |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-678 68462-679 68462-680 |
| Product NUI | N0000008486 |
| Drug UPC | 0368462680605 0368462681602 |
| Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Recall Initiation Date | 20250313 |
| Report Date | 20250416 |
| Classification Date | 20250408 |
| Address | 750 Corporate DrN/A Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 563KS2PQY5 |
| Drug Application Number | ANDA205006 |
| Structured Product Labeling (SPL ID) | a65056ce-b6e9-4bed-adbd-98052a2e705e |
| Structured Product Labeling (SPL Set ID) | df1d2e6a-6129-49c9-b2c1-0fdf73f38b9c |
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