Drug 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
Lots and codes
NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
Recall details
- Recalling firm
- Sagent Pharmaceuticals Inc, Schaumburg, IL
- Quantity
- 10,622 bags
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 4, 2014
- Terminated
- July 7, 2016
Related products
- Zoledronic acid – drug information
- NDC 25021-830 Zoledronic acid · Zoledronic Acid .05 mg/mL · Sagent Pharmaceuticals