Fluconazole Injection — Class II drug recall D-0780-2016
Terminated recall by Sagent Pharmaceuticals Inc, reported 2016-03-30, distributed nationwide. Cross contamination with other products: metronidazole
| Recall number | D-0780-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals Inc, Schaumburg, IL, United States |
| Recall initiated | 2016-03-01 |
| Classified | 2016-03-22 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2017-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 37,450 bags |
| NDC | 25021-0113-82 |
| Lot numbers | 40608, 5/17 |
Product
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
Reason for recall
Cross contamination with other products: metronidazole
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-0780-2016. 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.