ENOXAPARIN SODIUM Recall D-0179-2024
Description: Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
ENOXAPARIN SODIUM Recall D-0179-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0179-2024 |
| Event ID | 89450 |
| Brand | ENOXAPARIN SODIUM |
| Generic Name | ENOXAPARIN SODIUM |
| Manufacturer | ENOXAPARIN SODIUM |
| Original Package? | 1 |
| Active Substance | ENOXAPARIN SODIUM |
| Drug Route | SUBCUTANEOUS |
| Distribution | Nationwide USA |
| Quantity | 2 units |
| 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 | 0781-3238 0781-3246 0781-3256 |
| 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 | 8NZ41MIK1O |
| Drug Application Number | ANDA077857 |
| Structured Product Labeling (SPL ID) | f4e78371-47e9-4512-a435-de184591fbb7 |
| Structured Product Labeling (SPL Set ID) | 38f60bd8-b518-4098-a808-b8f5a3ae6a3a |
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