FDA Drug recall D-1615-2014
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 Intravenou…
- FDA Drug
- Class II
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class II recall of 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 Intravenou… by Sagent Pharmaceuticals, citing lack of Assurance of Sterility; leaking of premix bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1615-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-04 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sagent Pharmaceuticals |
| Distribution | US |
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
Lack of Assurance of Sterility; leaking of premix bags
Identifiers
| ndc | 25021-830-82 |
|---|---|
| ndc | 25021-830-87 |
| code_info | NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1615-2014%22
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