Fresenius Kabi USA LLC (FK USA) recalls IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmac
Recalled August 28, 2013 · FDA recall D-915-2013 · Fresenius Kabi USA LLC (FK USA)
Hazard
Crystallization: Active pharmaceutical ingredient is precipitating in product solution. · FDA Class II
Units
23,672 vials
Sold at
Nationwide
Description
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Product
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
Manufacturer(s)
Fresenius Kabi USA LLC (FK USA)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →