Home / Recalls / Genentech, Inc. / D-0509-2024

D-0509-2024 Class II Terminated

Recalled by Genentech, Inc. — South San Francisco, CA

Recall Details

Product Type
Drugs
Report Date
June 5, 2024
Initiation Date
May 20, 2024
Termination Date
August 11, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Lot:3618858 = 105,759; Lot:3618873 =90,359

Product Description

Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64

Reason for Recall

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 3618858, 3618873, Exp. Date 01/31/2026

Other recalls by Genentech, Inc.

  • D-0025-2023 Class III — Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing (October 18, 2022)
  • D-0650-2021 Class II — Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Su (June 9, 2021)
  • D-0357-2021 Class III — Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volum (April 20, 2021)
  • D-0416-2018 Class III — Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, (February 5, 2018)
  • D-1175-2017 Class I — Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 (September 5, 2017)
  • D-0648-2017 Class II — Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzer (March 13, 2017)
  • D-097-2013 Class III — CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count (September 27, 2012)
  • D-088-2013 Class II — Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, (September 20, 2012)
  • D-087-2013 Class II — Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, (September 20, 2012)
  • D-135-2013 Class I — Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL (July 30, 2012)