WARFARIN SODIUM Recall D-0201-2024
Description: Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
WARFARIN SODIUM Recall D-0201-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0201-2024 |
| Event ID | 89450 |
| Brand | WARFARIN SODIUM |
| Generic Name | WARFARIN SODIUM |
| Manufacturer | WARFARIN SODIUM |
| Original Package? | 1 |
| Active Substance | WARFARIN SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 1 unit |
| Recall Reason | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 0093-1712 0093-1713 0093-1714 |
| Drug UPC | 0300931712011 0300931713018 0300931718013 |
| Recall Initiation Date | 20220126 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 7200 Cardinal Pl W Dublin, OH 43017-1094 United States |
| Recalling Firm | CARDINAL HEALTHCARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6153CWM0CL |
| Drug Application Number | ANDA040616 |
| Structured Product Labeling (SPL ID) | 0f94f9e0-7215-4b46-b12a-33eae411c533 |
| Structured Product Labeling (SPL Set ID) | 0cbce382-9c88-4f58-ae0f-532a841e8f95 |
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