Genentech Inc: Drug Recall

Recall #D-0025-2023 · 10/18/2022

Class III: Low Risk

Recall Details

Recall Number: D-0025-2023
Classification: Class III
Product Type: Drug
Recalling Firm: Genentech Inc
Status: Terminated
Date Initiated: 10/18/2022
Location: South San Francisco, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 452 vials and implants

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.

Product 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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Genentech Inc

Class II: Risk 05/20/2024

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class II: Risk 06/09/2021

Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class III: Low Risk 04/20/2021

Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.

View all recalls by Genentech Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.