FDA Drug recall D-0025-2023
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill…
- FDA Drug
- Class III
- terminated
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class III recall of Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill… by Genentech, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0025-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-10-18 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Genentech |
| Distribution | US |
Product
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.
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.
Identifiers
| ndc | 50242-078-12 |
|---|---|
| ndc | 50242-078-55 |
| ndc | 8100425900 |
| ndc | 0081004259 |
| code_info | Lot/Exp: a) 3499188, Exp 10/31/2022; Lot 3523071, Exp 6/30/2023; b) 3456735, Exp 10/23/2026; 3456737; Exp 10/29/2026; 3…Lot/Exp: a) 3499188, Exp 10/31/2022; Lot 3523071, Exp 6/30/2023; b) 3456735, Exp 10/23/2026; 3456737; Exp 10/29/2026; 3477671, Exp 10/31/2026; 3480781, Exp 12/19/2026; 3506526, Exp 02/25/2027; 3506531, Exp 04/15/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0025-2023%22
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