Fresenius Kabi USA, LLC recalls ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceutica
Recalled December 17, 2014 · FDA recall D-0296-2015 · Fresenius Kabi USA
Hazard
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. · FDA Class II
Units
184,550 Vials
Sold at
U.S. Nationwide Including Puerto Rico
Description
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Product
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →