Reported Nov 9, 2022 · Terminated
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One…
Genentech Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Genentech Inc · 1 Dna Way · South San Francisco, CA · 94080-4918
Is this the product you have?
- 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.
- Lot codes and dates
- Lot/Exp
a) 3499188Exp 10/31/2022Lot 3523071Exp 6/30/2023b) 3456735Exp 10/23/20263456737Exp 10/29/20263477671Exp 10/31/20263480781Exp 12/19/20263506526Exp 02/25/20273506531Exp 04/15/2027
- Lot/Exp
- Amount recalled
- 452 vials and implants
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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