D-1615-2014 Class II Terminated
FDA drug recall D-1615-2014 was initiated by Sagent Pharmaceuticals Inc on Mar 4, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; leaking of premix bags The recall status is terminated (terminated Jul 7, 2016). Affected quantity: 10,622 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 8, 2014
- Initiation Date
- Mar 4, 2014
- Termination Date
- Jul 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,622 bags
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
Distribution Pattern
Nationwide
Code Information
NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1615-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026