PRAVASTATIN SODIUM Recall D-0341-2025
Description: Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
PRAVASTATIN SODIUM Recall D-0341-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0341-2025 |
| Event ID | 96474 |
| Brand | PRAVASTATIN SODIUM |
| Generic Name | PRAVASTATIN SODIUM |
| Manufacturer | PRAVASTATIN SODIUM |
| Original Package? | 1 |
| Active Substance | PRAVASTATIN SODIUM |
| Drug Route | ORAL |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68462-195 68462-196 68462-197 |
| Drug UPC | 0368462195901 0368462198902 |
| 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 | 3M8608UQ61 |
| Drug Application Number | ANDA077987 |
| Structured Product Labeling (SPL ID) | a6e006b3-4256-4cbb-8ad1-b71f363430cd |
| Structured Product Labeling (SPL Set ID) | 6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4 |
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