November 16, 2018
A lack of assurance of sterility has prompted Avella of Deer Valley Inc. to pull a single lot of bevacizumab 2.5 mg/0.1mL prefilled syringes (NDC 42852-001-24), according to the November 14, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The 911 bevacizumab syringes affected contain a deliverable dose of 1.25 mg and are from lot 138-20182408@58, which has a beyond-use date of December 22, 2018. The product was repackaged by Avella Specialty Pharmacy and distributed throughout the United States.
Avella of Deer Valley voluntarily initiated the recall October 31, 2018. On November 7, 2018, the FDA designated the recall Class II. A Class II designation communicates that use of the recalled product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Bevacizumab injection is used with chemotherapy to treat kidney, colon, and rectal cancer.
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