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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