Genentech, Inc.

4 FDA enforcement actions

4 Total Recalls

0 Class I

2 Class II

2 Class III

Firm Details

Product Types: drug
States: CA

All Recalls

Class II: Risk 05/20/2024 drug

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class III: Low Risk 10/18/2022 drug

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.
Class II: Risk 06/09/2021 drug

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 04/20/2021 drug

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.