Drug Enforcement D-0025-2023

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.

Status

Terminated

Classification

Class III

Report Date

November 9, 2022

Termination Date

April 17, 2024

Product Information

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.
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Genentech Inc
Address
1 Dna Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0025-2023
Event ID
90959
Recall initiation date
October 18, 2022
Center classification date
November 1, 2022
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 code info
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