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.
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0025-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 18, 2022
- FDA report date
- Nov 9, 2022
- Quantity
- 452 vials and implants
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genentech Inc
Original FDA data
Every field from FDA enforcement report D-0025-2023, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 90959
- Address
- 1 Dna Way
- Code information
- 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
- Postal code
- 94080-4918
- Report date
- Nov 9, 2022
- Product type
- Drugs
- Recall number
- D-0025-2023
- Classification
- Class III
- Recalling firm
- Genentech Inc
- Product quantity
- 452 vials and implants
- Termination date
- Apr 17, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Oct 18, 2022
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2022