FDA Drug recall D-0380-2015
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 INTRAVI…
- FDA Drug
- Class II
- terminated
- Published 2015-02-04
On 2015-02-04 the FDA classified a Class II recall of 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 INTRAVI… by Baxter Healthcare, citing lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0380-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-23 |
| Published | 2015-02-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Identifiers
| ndc | 0338-6046-48 |
|---|---|
| ndc | 0338-6045-37 |
| code_info | Lot #: P318394; Exp 05/31/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0380-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.