Why it was recalled
Defective container: loose crimp defect, potential loss of container integrity.
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 numbers, UPCs & expiration codes
Lots: 1142258, 1143196, Exp. 09/24
Where it was sold
Nationwide in the USA, Egypt and Lithuania.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0855-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2022
- FDA report date
- May 18, 2022
- Quantity
- 15,823
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amgen, Inc.
Original FDA data
Every field from FDA enforcement report D-0855-2022, exactly as published.
Show all FDA fields
- City
- Thousand Oaks
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 90112
- Address
- 1 Amgen Center Dr
- Code information
- Lots: 1142258, 1143196, Exp. 09/24
- Postal code
- 91320-1730
- Report date
- May 18, 2022
- Product type
- Drugs
- Recall number
- D-0855-2022
- Classification
- Class II
- Recalling firm
- Amgen, Inc.
- Product quantity
- 15,823
- Termination date
- Dec 2, 2022
- Reason for recall
- Defective container: loose crimp defect, potential loss of container integrity.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA, Egypt and Lithuania.
- Recall initiation date
- May 2, 2022
- Initial firm notification
- Letter
- Center classification date
- May 9, 2022