Drug 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
D-0855-2022
Product summary
- Firm
- Amgen, Inc.
- Event
- Event 90112
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,823
- Official record key
drug-enforcement:D-0855-2022
Official wording
Reason: Defective container: loose crimp defect, potential loss of container integrity.
Code information: Lots: 1142258, 1143196, Exp. 09/24
Distribution pattern: Nationwide in the USA, Egypt and Lithuania.
Derived failure modes
-
Unknown
Defective container: loose crimp defect, potential loss of container integrity.