Cancer Drug Recalled

Defective containers have prompted Amgen Inc to recall 2 lots of Mvasi (bevacizumab-awwb) injection. The May 18, 2022, US Food and Drug Administration (FDA) Enforcement Report cites a loose crimp defect and potential loss of container integrity.

The recall affects Mvasi, 100 mg/4 mL, single-dose vials (NDC 55513-0206-01), from lots 1142258 and 1143196 (Exp. 9/24). The affected vials, manufactured by Amgen Inc, Thousand Oaks, CA, were distributed throughout the United States as well as in Egypt and Lithuania.

Amgen voluntarily initiated the recall May 2, 2022. On May 9, 2022, the FDA designated the recall Class II. The classification communicates that use of the affected medication could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Mvasi is a prescription drug, biosimilar to Avastin (bevacizumab), indicated in the treatment of metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, and ovarian cancer.