FROVATRIPTAN SUCCINATE Recall D-0322-2025
Description: Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97
FROVATRIPTAN SUCCINATE Recall D-0322-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0322-2025 |
| Event ID | 96474 |
| Brand | FROVATRIPTAN SUCCINATE |
| Generic Name | FROVATRIPTAN SUCCINATE |
| Manufacturer | FROVATRIPTAN SUCCINATE |
| Original Package? | 1 |
| Active Substance | FROVATRIPTAN SUCCINATE |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-694 |
| Drug UPC | 0368462694978 |
| 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 | D28J6W18HY |
| Drug Application Number | ANDA204730 |
| Structured Product Labeling (SPL ID) | 49e68dd9-06c7-4d54-afa9-9016ae0b6995 |
| Structured Product Labeling (SPL Set ID) | 03a58215-dba7-4f63-8b98-d74d054a574a |
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