FDA Drug recall D-0788-2017
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deer…
- FDA Drug
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deer… by Baxter Healthcare, citing lack of assurance of sterility: customer complaints received for the presence of leaks.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0788-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-15 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
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
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Identifiers
| ndc | 0338-6046-48 |
|---|---|
| ndc | 0338-6045-37 |
| code_info | Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18 |
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-0788-2017%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.