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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

MVASI (bevacizumab-awwb) Injection Recalled for Defective Container Integrity

Agency Publication Date: May 9, 2022
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Summary

Amgen, Inc. has recalled MVASI (bevacizumab-awwb) Injection, 100 mg/4 ml, after discovering a defect where the vial container crimp may be loose. This recall affects approximately 15,823 units that were distributed nationwide to hospitals, clinics, and pharmacies. The loose seal could result in a loss of container integrity, potentially leading to leakage or medication contamination. No injuries or incidents have been reported to date.

Risk

A loose crimp defect can compromise the sterile seal of the vial, potentially allowing microorganisms to contaminate the medication. If contaminated medication is administered intravenously, it could cause serious infections or other adverse health consequences for the patient.

What You Should Do

  1. This recall affects MVASI (bevacizumab-awwb) Injection, 100 mg/4 ml single-dose vials (NDC 55513-0206-01) with lot numbers 1142258 and 1143196, both with an expiration date of September 2024 (09/24).
  2. Stop using the recalled product immediately.
  3. Contact Amgen, Inc. or your wholesale distributor to arrange for the return of any remaining affected vials.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: MVASI (bevacizumab-awwb) Injection (100 mg/4 ml)
Variants: 100 mg/4 ml, Single dose vial, Rx only
Lot Numbers:
1142258 (Exp. 09/24)
1143196 (Exp. 09/24)
NDC:
55513-0206-01

Recall #: D-0855-2022; Total Quantity: 15,823 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90112
Status: Resolved
Manufacturer: Amgen, Inc.
Sold By: hospitals; clinics; pharmacies
Manufactured In: United States
Units Affected: 15,823
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.