Recalls / Class II
Class IID-0855-2022
Product
MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01
- Affected lot / code info
- Lots: 1142258, 1143196, Exp. 09/24
Why it was recalled
Defective container: loose crimp defect, potential loss of container integrity.
Recalling firm
- Firm
- Amgen, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Amgen Center Dr, N/A, Thousand Oaks, California 91320-1730
Distribution
- Quantity
- 15,823
- Distribution pattern
- Nationwide in the USA, Egypt and Lithuania.
Timeline
- Recall initiated
- 2022-05-02
- FDA classified
- 2022-05-09
- Posted by FDA
- 2022-05-18
- Terminated
- 2022-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0855-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.