Class III
Terminated
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.
- Company
- Genentech, Inc.
- Recall Initiated
- October 18, 2022
- Posted
- November 9, 2022
- Recall Number
- D-0025-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 452 vials and implants
- Firm Location
- South San Francisco, CA, United States
Reason for Recall
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.
Distribution
Nationwide in the USA
Lot / 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; 3477671, Exp 10/31/2026; 3480781, Exp 12/19/2026; 3506526, Exp 02/25/2027; 3506531, Exp 04/15/2027
More recalls by Genentech, Inc.
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC...
Jun 5, 2024 · Class II
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Sing...
Jul 14, 2021 · Class II
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution...
May 5, 2021 · Class III
Other recent Class III Drug recalls
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Via...
Slate Run Pharmaceuticals
· Mar 4, 2026
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceutica...
Unichem Pharmaceuticals Usa Inc.
· Feb 18, 2026
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),...
Haleon Us Holdings Llc
· Feb 4, 2026
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceutic...
Novadoz Pharmaceuticals Llc
· Feb 4, 2026
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd.,...
Cipla Usa, Inc.
· Jan 28, 2026