Drug 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
D-1615-2014
Product summary
- Event
- Event 67689
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,622 bags
- Official record key
drug-enforcement:D-1615-2014
Official wording
Reason: Lack of Assurance of Sterility; leaking of premix bags
Code information: NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility