Zoledronic Acid Injection 5 mg per 100 mL — Class II drug recall D-1615-2014
Terminated recall by Sagent Pharmaceuticals Inc, reported 2014-10-08, distributed nationwide. Lack of Assurance of Sterility; leaking of premix bags
| Recall number | D-1615-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals Inc, Schaumburg, IL, United States |
| Recall initiated | 2014-03-04 |
| Classified | 2014-09-29 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2016-07-07 |
| Distributed | Nationwide (US) |
| Quantity | 10,622 bags |
| Reason classes | sterility, packaging |
| NDC | 25021-0830, 25021-0830-82, 25021-0830-87 |
| Lot numbers | 30076, 30077 |
| Expiration dates | 2015-01 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1615-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.