June 26, 2020
Reports of defective containers have prompted Hikma Pharmaceuticals USA Inc. to recall more than 100,000 vials of irinotecan hydrochloride injection. According to the June 24, 2020, US Food and Drug Administration (FDA) Enforcement Report, customers have reported crimp defects upon removing the vial’s flip cap.
The recall affects the following products, which were manufactured by Thymoorgan Pharmazie GmbH and distributed within the United States by West-Ward Pharmaceutical Corporation:
- irinotecan hydrochloride injection, 100 mg/5 mL, 5-mL vials (NDC 0143-9583-01) from lot AC0231A (Exp. 8/21); and
- irinotecan hydrochloride injection, 100 mg/5 mL, 5-mL vials (NDC 0143-9701-01) from lots AC0231 and AC0235 (Exp. 8/21), and AC0237 (Exp. 9/21).
Hikma Pharmaceuticals USA voluntarily initiated the recall June 11, 2020. On June 12, 2020, 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 medication used to treat patients with cancer of the colon or rectum.