Fluconazole Injection — Class II drug recall D-0788-2017
Terminated recall by Baxter Healthcare Corporation, reported 2017-05-24. Lack of assurance of sterility: customer complaints received for the presence of leaks.
| Recall number | D-0788-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2017-05-15 |
| Classified | 2017-05-18 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2018-08-10 |
| Countries outside the US | AE, CA, CO |
| Quantity | 113,590 bags |
| Reason classes | sterility, packaging |
| NDC | 00338-6045, 00338-6045-37, 00338-6046, 00338-6046-48 |
| Lot numbers | P344028/P344028A, P348136, P352377 |
| Expiration dates | 2017-12-31, 2018-04-30, 2018-08-31 |
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: customer complaints received for the presence of leaks.
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-0788-2017. 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.