Product Safety Recalls

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RANIBIZUMAB Recall D-0025-2023

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.

RANIBIZUMAB Recall D-0025-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0025-2023
Event ID90959
Original Package?1
Active SubstanceRANIBIZUMAB
DistributionNationwide in the USA
Quantity452 vials and implants
Recall ReasonDefective 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.
Drug ClassificationClass III
Drug Code Info20221109
Product NDC50242-078
Product NUIN0000193542 N0000193543
Pharma Class (EPC)Vascular Endothelial Growth Factor Inhibitor [EPC]
Recall Initiation Date20221018
Report Date20221109
Classification Date20221101
Address1 Dna Way
South San Francisco, CA 94080-4918
United States
Recalling FirmGenentech Inc
Initial Notification Letter
Unique Ingredient IdentifierZL1R02VT79
Drug Application NumberBLA761197
Structured Product Labeling (SPL ID)5f04121a-b0ec-41f6-9e21-eacb0e8609e0
Structured Product Labeling (SPL Set ID)9c6d9e2a-9a77-4d11-b692-de87cfde3444
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