Recalls / Class I
Class ID-1175-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.
Why it was recalled
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Recalling firm
- Firm
- Genentech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Dna Way, N/A, South San Francisco, California 94080-4990
Distribution
- Quantity
- 16,882
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-09-05
- FDA classified
- 2017-12-01
- Posted by FDA
- 2017-09-27
- Terminated
- 2019-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1175-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.