FDA-Drug2014-10-08Class II
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
Sagent Pharmaceuticals Inc
Hazard
Lack of Assurance of Sterility; leaking of premix bags
Sold states
Nationwide
Affected count
10,622 bags
Manufactured in
1901 N Roselle Rd Ste 700, N/A, Schaumburg, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1615-2014Don't want to check this manually?
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