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
Reported: October 8, 2014 Initiated: March 4, 2014 #D-1615-2014
Product Description
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
Details
- Recalling Firm
- Sagent Pharmaceuticals Inc
- Units Affected
- 10,622 bags
- Distribution
- Nationwide
- Location
- Schaumburg, IL
Frequently Asked Questions
What product 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. Recalled by Sagent Pharmaceuticals Inc. Units affected: 10,622 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility; leaking of premix bags
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 8, 2014. Severity: Moderate. Recall number: D-1615-2014.
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