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-0788-2017
Product summary
- Event
- Event 77247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 113,590 bags
- Official record key
drug-enforcement:D-0788-2017
Official wording
Reason: Lack of assurance of sterility: customer complaints received for the presence of leaks.
Code information: Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18
Distribution pattern: US and foreign countries: United Arab Emirates, Colombia, and Canada
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility