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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