Class I
Terminated
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
- Company
- Genentech, Inc.
- Recall Initiated
- September 5, 2017
- Posted
- September 27, 2017
- Recall Number
- D-1175-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,882
- Firm Location
- South San Francisco, CA, United States
Reason for Recall
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Distribution
Nationwide in the USA
Lot / Code Info
Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
More recalls by Genentech, Inc.
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC...
Jun 5, 2024 · Class II
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-...
Nov 9, 2022 · Class III
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Sing...
Jul 14, 2021 · Class II
Other recent Class I Drug recalls
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactu...
Mckesson
· Feb 18, 2026
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLu...
Green Lumber Holdings, Llc
· Feb 11, 2026
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India...
Handelnine Global Llc
· Feb 11, 2026
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNat...
Medinatura New Mexico, Inc.
· Jan 14, 2026
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, L...
Fresenius Kabi Usa, Llc
· Dec 3, 2025