Recall: D-0296-2015

Class II - Potentially Harmful

Class IIClassification

2012-09-27Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

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

Reason

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

Distribution

U.S. Nationwide Including Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.