Drug 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.
D-0380-2015
Product summary
- Event
- Event 70057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,130 bags
- Official record key
drug-enforcement:D-0380-2015
Official wording
Reason: Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Code information: Lot #: P318394; Exp 05/31/16
Distribution pattern: Nationwide, United Arab Emirates, and Columbia
Derived failure modes
-
Labeling or packaging
incomplete seal
-
Sterility assurance
Lack of Assurance of Sterility