March 05, 2021
Areva Pharmaceuticals Inc. is recalling a single lot of irinotecan hydrochloride injection. The voluntary recall is “based on a warning letter received by the manufacturer of the recalled product for inadequate out-of-specification investigations, complaint, and the investigation conclusions,” according to the March 3, 2021, US Food and Drug Administration (FDA) Enforcement Report.
Recalled are 2-mL single-dose vials of irinotecan hydrochloride injection, 40 mg/2 mL (20 mg/mL; NDC 59923-714-02) from lot 7S10022A (Exp. 1/21). The product was made in India and distributed by Areva Pharmaceuticals throughout the United States.
Areva Pharmaceuticals initiated the recall November 19, 2020. On February 21, 2021, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Irinotecan is a prescription chemotherapy drug used to treat cancer of the colon or rectum.