Fluconazole Injection — Class II drug recall D-0206-2017
Terminated recall by Baxter Healthcare Corporation, reported 2016-12-28. Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
| Recall number | D-0206-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2016-12-06 |
| Classified | 2016-12-19 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2018-02-12 |
| Countries outside the US | AE, CO |
| Quantity | 30,910 bags |
| Reason classes | sterility, packaging |
| NDC | 00338-6045, 00338-6045-37, 00338-6046, 00338-6046-48 |
| Lot numbers | P344028 |
| Expiration dates | 2017-12-31 |
Product
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.
Reason for recall
Lack of Assurance of Sterility: confirmed customer complaints of leaking 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-0206-2017. 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.