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 30076Expires 01/2015Lot 30077Expires 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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