Drug 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.
D-0206-2017
Product summary
- Event
- Event 75831
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,910 bags
- Official record key
drug-enforcement:D-0206-2017
Official wording
Reason: Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Code information: Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017
Distribution pattern: United States, United Arab Emirates, and Colombia
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility