drugs Class II Updated 2014-12-17

Fresenius Kabi USA, LLC recalls ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 6003930, exp. date 04/2014
View official government recall

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