Genentech, Inc. FDA Recalls

4 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64Class IIMay 20, 2024Lack of Assurance of Sterility: Deformed stoppers observed d	Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.	Class IIDrugs	May 20, 2024
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One SuClass IIIOct 18, 2022Defective Delivery System: Commercial implants do not meet t	Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few	Class IIIDrugs	Oct 18, 2022
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled SyClass IIJun 9, 2021Failed Stability Specifications: Out of Specification result	Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected a	Class IIDrugs	Jun 9, 2021
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, DistributClass IIIApr 20, 2021Defective Container: complaints received regarding some inco	Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorre	Class IIIDrugs	Apr 20, 2021