The Recall Desk
HighFDA (Drugs)·D-0855-2022·Announced 2022-05-18

MVASI Cancer Drug Recalled for Loose Container Crimp

Amgen is recalling specific lots of MVASI (bevacizumab-awwb) injection due to a loose crimp defect in the container that could compromise container integrity. Patients should contact their healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall for a defective injectable container (loose crimp) that could compromise container integrity and sterility. The hazard represents a risk of harm to patients, though no illnesses or injuries have been reported.

Plain-English summary

MVASI (bevacizumab-awwb) is an injectable cancer drug manufactured by Amgen Inc. that is administered by intravenous infusion. The FDA has classified this recall as Class II.

Certain lots of MVASI have been found to have a defective container with a loose crimp, which could result in potential loss of container integrity. Container integrity is critical for injectable medications to maintain sterility and safety.

The recall affects lots 1142258 and 1143196 (expiration 09/24), with a total of 15,823 units distributed nationwide in the USA, as well as in Egypt and Lithuania. Patients who have received or may receive this product should contact their healthcare provider immediately to discuss their treatment options.

Healthcare providers and distributors should stop dispensing affected lots immediately and quarantine any remaining product.

The recalled product

Product
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
Manufacturer
Amgen, Inc.
Hazard
  • loose-crimp
  • container-integrity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lots: 1142258
  • 1143196
  • Exp. 09/24

Distribution

Distributed nationwide across the United States.