SOLIFENACIN SUCCINATE Recall D-0333-2025
Description: Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
SOLIFENACIN SUCCINATE Recall D-0333-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0333-2025 |
| Event ID | 96474 |
| Brand | SOLIFENACIN SUCCINATE |
| Generic Name | SOLIFENACIN SUCCINATE |
| Manufacturer | SOLIFENACIN SUCCINATE |
| Original Package? | 1 |
| Active Substance | SOLIFENACIN 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 | 68462-386 68462-387 |
| Drug UPC | 0368462386309 0368462387306 |
| 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 | KKA5DLD701 |
| Drug Application Number | ANDA209239 |
| Structured Product Labeling (SPL ID) | 9cfcab1d-64ac-457b-979f-41cf6547a63a |
| Structured Product Labeling (SPL Set ID) | 010c0657-c907-477f-8bd7-5d455a5f50eb |
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