PROCHLORPERAZINE MALEATE Recall D-0338-2025
Description: Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01
PROCHLORPERAZINE MALEATE Recall D-0338-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0338-2025 |
| Event ID | 96474 |
| Brand | PROCHLORPERAZINE MALEATE |
| Generic Name | PROCHLORPERAZINE MALEATE |
| Manufacturer | PROCHLORPERAZINE MALEATE |
| Original Package? | 1 |
| Active Substance | PROCHLORPERAZINE MALEATE |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-889 68462-890 |
| Drug UPC | 0368462889015 0368462890011 |
| 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 | I1T8O1JTL6 |
| Drug Application Number | ANDA216595 |
| Structured Product Labeling (SPL ID) | 97669459-dece-4f75-b27d-372b4a3e815e |
| Structured Product Labeling (SPL Set ID) | 9c806152-70d0-43eb-b183-b51b12b82b31 |
| Similar To |