# FDA recall D-0025-2023

> **Genentech Inc** · Class III · drug recall initiated 2022-10-18.

## Product

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.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0025-2023
- **Recalling firm:** Genentech Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-10-18
- **Report date:** 2022-11-09
- **Termination date:** 2024-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South San Francisco, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0025-2023

## Citation

> AI Analytics. FDA recall D-0025-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0025-2023. Source: US FDA. Licensed CC0.

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