AFLIBERCEPT Recall D-0531-2024
Description: EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54
AFLIBERCEPT Recall D-0531-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0531-2024 |
| Event ID | 94646 |
| Brand | EYLEA |
| Generic Name | AFLIBERCEPT |
| Manufacturer | AFLIBERCEPT |
| Original Package? | 1 |
| Active Substance | AFLIBERCEPT |
| Drug Route | INTRAVITREAL |
| Distribution | USA nationwide. |
| Quantity | 405,725 Prefilled syringes |
| Recall Reason | Lack of Assurance of Sterility: Complaints of syringe breakage |
| Drug Classification | Class II |
| Drug Code Info | 20240605 |
| Product NDC | 61755-005 |
| Product NUI | N0000193543 N0000193542 |
| Drug UPC | 258231500336 |
| Pharma Class (EPC) | Vascular Endothelial Growth Factor Inhibitor [EPC] |
| Recall Initiation Date | 20240515 |
| Report Date | 20240605 |
| Classification Date | 20240530 |
| Address | 777 Old Saw Mill River Rd Tarrytown, NY 10591-6717 United States |
| Recalling Firm | Regeneron Pharmaceuticals Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 15C2VL427D |
| Drug Application Number | BLA125387 |
| Structured Product Labeling (SPL ID) | 16021fa7-8b7d-4c07-b1d9-9d9140ffdfdf |
| Structured Product Labeling (SPL Set ID) | f96cfd69-da34-41ee-90a9-610a4655cd1c |
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