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

Recall Number: D-0296-2015

Firm: Fresenius Kabi USA, LLC

Classification: Class II

Status: Terminated

Report Date: 20141217

Initiation Date: 20120927

Termination Date: 20141212

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

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