D-0855-2022 Class II Terminated
FDA drug recall D-0855-2022 was initiated by Amgen, Inc. on May 2, 2022 and is designated Class II. Reason for recall: Defective container: loose crimp defect, potential loss of container integrity. The recall status is terminated (terminated December 2, 2022). Affected quantity: 15,823.
Recall Details
- Product Type
- Drugs
- Report Date
- May 18, 2022
- Initiation Date
- May 2, 2022
- Termination Date
- December 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,823
Product Description
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
Reason for Recall
Defective container: loose crimp defect, potential loss of container integrity.
Distribution Pattern
Nationwide in the USA, Egypt and Lithuania.
Code Information
Lots: 1142258, 1143196, Exp. 09/24