Drug product
ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-1027-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 916 total units
- Official record key
drug-enforcement:D-1027-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 01042016:74@36, Exp. 07/03/2016; Lot #: 01052016:14@12, Exp.06/18/2016; Lot #: 01272016:70@17, Exp. 07/25/2016; Lot #:02222016:62@12, Exp.08/24/2016; Lot #:03212016:57@30, Exp. 09/17/2016; Lot #: 04182016:42@44, Exp.10/16/2016; Lot #:05012016:18@29, Exp.11/01/2016.
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility