Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Susvimo (ranibizumab injection)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDC
50242-0078-55
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Susvimo Ranibizumab NDC 50242-0078 |
100 mg/mL | Injection, Solution Intravitreal |
Genentech, Inc. | Rx |
- Recalling firm
- Genentech Inc
- NDC code
- 50242-078-55
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0025-2023 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Genentech Inc
All 2022 recalls
Class II · Moderate risk
Xolair (omalizumab)
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class III · Low risk
Evrysdi (risdiplam)
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Class III · Low risk
Klonopin (clonazepam)
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Other packaging defect recalls from 2022
All packaging defect recalls
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
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