Reported Oct 8, 2014 · Terminated

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

Sagent Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sagent Pharmaceuticals Inc · 1901 N Roselle Rd Ste 700 · Schaumburg, IL · 60195-3194

Is this the product you have?

  • 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
Lot codes and dates
  • NDC 25021-830-82
  • Lot Numbers and Expiration Dates
    • Lot 30076
    • Expires 01/2015
    • Lot 30077
    • Expires 01/2015
Amount recalled
10,622 bags

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility; leaking of premix bags

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 7, 2016 · Data as of Sep 19, 5:03 PM UTC

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