RANIBIZUMAB Recall D-0025-2023
Description: Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.
RANIBIZUMAB Recall D-0025-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0025-2023 |
| Event ID | 90959 |
| Brand | SUSVIMO |
| Generic Name | RANIBIZUMAB |
| Manufacturer | RANIBIZUMAB |
| Original Package? | 1 |
| Active Substance | RANIBIZUMAB |
| Drug Route | INTRAVITREAL |
| Distribution | Nationwide in the USA |
| Quantity | 452 vials and implants |
| Recall Reason | Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning. |
| Drug Classification | Class III |
| Drug Code Info | 20221109 |
| Product NDC | 50242-078 |
| Product NUI | N0000193542 N0000193543 |
| Pharma Class (EPC) | Vascular Endothelial Growth Factor Inhibitor [EPC] |
| Recall Initiation Date | 20221018 |
| Report Date | 20221109 |
| Classification Date | 20221101 |
| Address | 1 Dna Way South San Francisco, CA 94080-4918 United States |
| Recalling Firm | Genentech Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | ZL1R02VT79 |
| Drug Application Number | BLA761197 |
| Structured Product Labeling (SPL ID) | 5f04121a-b0ec-41f6-9e21-eacb0e8609e0 |
| Structured Product Labeling (SPL Set ID) | 9c6d9e2a-9a77-4d11-b692-de87cfde3444 |
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