FDA recall D-1615-2014

Product

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

Reason for recall

Lack of Assurance of Sterility; leaking of premix bags

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-03-04

Report date

2014-10-08

Termination date

2016-07-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1615-2014