WARFARIN SODIUM Recall D-0348-2023
Description: Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
WARFARIN SODIUM Recall D-0348-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0348-2023 |
| Event ID | 91713 |
| Brand | WARFARIN SODIUM |
| Generic Name | WARFARIN SODIUM |
| Manufacturer | WARFARIN SODIUM |
| Original Package? | 1 |
| Active Substance | WARFARIN SODIUM |
| Drug Route | ORAL |
| Distribution | Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide. |
| Quantity | 12,216 bottles (100 count each) |
| Recall Reason | Failed Impurities/Degradation Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20230301 |
| Product NDC | 57237-119 57237-120 57237-121 |
| Recall Initiation Date | 20230215 |
| Report Date | 20230301 |
| Classification Date | 20230223 |
| Address | 2 Tower Center Blvd East Brunswick, NJ 08816-1100 United States |
| Recalling Firm | RISING PHARMACEUTICALS |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6153CWM0CL |
| Drug Application Number | ANDA090935 |
| Structured Product Labeling (SPL ID) | bab28da8-ce52-4caf-a5ef-8fa777aca739 |
| Structured Product Labeling (SPL Set ID) | 8373fced-93fe-44c6-93d9-8f21c6599f65 |
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