Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82
Recall Number: D-1615-2014
Firm: Sagent Pharmaceuticals Inc
Classification: Class II
Status: Terminated
Report Date: 20141008
Initiation Date: 20140304
Termination Date: 20160707
Reason for Recall
Lack of Assurance of Sterility; leaking of premix bags
Product Description
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82