Genentech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
11 (2 Class I)
510(k) Clearances
0
Inspections
43
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0509-2024Class IICathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDCMay 20, 2024
D-0025-2023Class IIISusvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-October 18, 2022
D-0650-2021Class IIXolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. SingJune 9, 2021
D-0357-2021Class IIIEvrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitutionApril 20, 2021
D-0416-2018Class IIIKlonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by GenenFebruary 5, 2018
D-1175-2017Class IActivase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml viSeptember 5, 2017
D-0648-2017Class IICotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed byMarch 13, 2017
D-097-2013Class IIICellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton,September 27, 2012
D-088-2013Class IINutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San FranciscoSeptember 20, 2012
D-087-2013Class IINutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San FranciscoSeptember 20, 2012
D-135-2013Class ITrastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial July 30, 2012