MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Ma
Summary
The FDA issued a Class II for MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 10 by Amgen, Inc.. Reason: Defective container: loose crimp defect, potential loss of container integrity..
Details
Source
Drug Recall
External ID
D-0855-2022
Action Date
2022-05-18
Status
Terminated
Category
drug
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
Lot/Code Info: Lots: 1142258, 1143196, Exp. 09/24
Quantity Affected: 15,823
Reason for Recall
Defective container: loose crimp defect, potential loss of container integrity.
Distribution
Nationwide in the USA, Egypt and Lithuania.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-02
Company
Thousand Oaks, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amgen, Inc. has 9 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amgen, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amgen, Inc. have FDA actions?
Amgen, Inc. has 9 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0855-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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