Recalls / Class III
Class IIID-0025-2023
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.
- Brand name
- Susvimo
- Generic name
- Ranibizumab
- Active ingredient
- Ranibizumab
- Route
- Intravitreal
- NDC
- 50242-078
- FDA application
- BLA761197
- Affected 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
Why it was recalled
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.
Recalling firm
- Firm
- Genentech Inc
- Manufacturer
- Genentech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Dna Way, N/A, South San Francisco, California 94080-4918
Distribution
- Quantity
- 452 vials and implants
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-10-18
- FDA classified
- 2022-11-01
- Posted by FDA
- 2022-11-09
- Terminated
- 2024-04-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0025-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.