Activase (Genentech) – Non-Sterile Packaging (2017)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Genentech, Inc.
Lot Codes / Batch Numbers
Lot# 3128243, 3141239, EXP. 9/30/2018, 3166728, EXP. 2/28/2019.
Products Sold
Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
Genentech, Inc. is recalling Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vi due to Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026