CLASS II Drug recall · Reported 18 May 2022 · FDA Enforcement Report
Mvasi (bevacizumab-awwb), Injection recalled by Amgen
Amgen is recalling Mvasi (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg, distributed nationwide in the US. The recall was initiated on 2 May 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0855-2022
- FDA event ID
- 90112
- Recalling firm
- Amgen, Thousand Oaks, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2022
- FDA classified
- 9 May 2022
- Reported
- 18 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 2 May 2022 | Recall initiated by company | |
| 9 May 2022 | Classified by FDA | +7 days |
| 18 May 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: loose crimp defect, potential loss of container integrity.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA, Egypt and Lithuania.
Questions about this recall
Why was it recalled?
Defective container: loose crimp defect, potential loss of container integrity.
Which lots are affected?
Lots: 1142258, 1143196, Exp. 09/24
Where was it sold?
Nationwide in the USA, Egypt and Lithuania.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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