PRAVASTATIN SODIUM Recall D-0350-2025
Description: Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
PRAVASTATIN SODIUM Recall D-0350-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0350-2025 |
| 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 | 16714-558 16714-559 16714-560 |
| Drug UPC | 0316714570013 0316714559018 0316714560014 |
| 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) | fa078b35-ee9d-4b9f-bb8d-e77949c09f88 |
| Structured Product Labeling (SPL Set ID) | ce15ad07-3286-478f-9f30-1db6a45ed402 |
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