Fluconazole Injection — Class II drug recall D-0380-2015
Terminated recall by Baxter Healthcare Corp., reported 2015-02-04, distributed nationwide. Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
| Recall number | D-0380-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-12-23 |
| Classified | 2015-01-26 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2016-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE |
| Quantity | 31,130 bags |
| Reason classes | sterility, packaging |
| NDC | 00338-6045, 00338-6045-37, 00338-6046, 00338-6046-48 |
| Lot numbers | P318394 |
| Expiration dates | 2016-05-31 |
Product
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.
Reason for recall
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
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-0380-2015. 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.