US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 4, 2014 (13 years ago)

Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility; leaking of premix bags

What was recalled

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

Recalling firm
Sagent Pharmaceuticals Inc
NDC code
25021-830-82
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1615-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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