FONDAPARINUX SODIUM Recall D-0020-2023
Description: Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)
FONDAPARINUX SODIUM Recall D-0020-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0020-2023 |
| Event ID | 90925 |
| Brand | FONDAPARINUX SODIUM |
| Generic Name | FONDAPARINUX SODIUM |
| Manufacturer | FONDAPARINUX SODIUM |
| Original Package? | 1 |
| Active Substance | FONDAPARINUX SODIUM |
| Drug Route | SUBCUTANEOUS |
| Distribution | Nationwide in the USA |
| Quantity | 11,520 units |
| Recall Reason | Subpotent Drug: Out of specification for assay |
| Drug Classification | Class II |
| Drug Code Info | 20221102 |
| Product NDC | 55150-230 55150-231 55150-232 |
| Recall Initiation Date | 20220930 |
| Report Date | 20221102 |
| Classification Date | 20221024 |
| Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
| Recalling Firm | AuroMedics Pharma LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | X0Q6N9USOZ |
| Drug Application Number | ANDA206918 |
| Structured Product Labeling (SPL ID) | bf1892c1-2d91-462a-aef1-09adcd01b59c |
| Structured Product Labeling (SPL Set ID) | 8ea61d0d-4403-4d9f-a946-85a459cc0aa0 |
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