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