Genentech Inc recalls Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One S…

Recall date

October 18, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0025-2023

FDA classification

Class III

Brand / firm

Genentech Inc

Sold / distributed

Nationwide in the USA

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.