Drug product
ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-1028-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 916 total units
- Official record key
drug-enforcement:D-1028-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 02102016:22@57, Exp. 08/08/2016; Lot #: 02292016:59@55 ,Exp. 08/28/2016; Lot #: 03072016:68@7, Exp. 09/03/2016; Lot #: 4052016:41@56, Exp. 10/04/2016; Lot #: 04192016:41@34, Exp.10/16/2016.
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility