Intravitreal Injection Recalled
Medivant Healthcare is recalling 27 560 syringes containing repackaged bevacizumab (Avastin) injection because of a lack of sterility assurance, according to the November 27, 2024, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects bevacizumab (Avastin) 1.25 mg/0.05 mL injection, 0.5-mL single-dose syringes (NDC 81483-0041-1), from lots D24005 (Exp. 2/20/25), D24006 (Exp. 2/21/25), D24007 (Exp. 2/22/25), D24008 (Exp. 3/19/25), D24009 (Exp. 3/20/25), and D24012 (Exp. 4/25/25). Medivant Healthcare repackaged the product and distributed it throughout the United States.
Medivant Healthcare voluntarily initiated the recall on November 6, 2024. On November 18, 2024, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Medivant Healthcare markets repackaged bevacizumab for ophthalmic use.