Drug product
M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-0994-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-0994-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 01042016: 45@46, Exp. 07/02/2016; Lot #:01112016: 87@46, Exp. 07/10/2016; Lot #:01112016:78@63, Exp. 07/10/2016; Lot #: 01272016:81@30, Exp.07/25/2016; Lot #: 02102016:89@2, Exp. 08/08/2016; 02162016:25@57, Exp.08/14/2016; 02262016:33@54, Exp.08/24/2016; Lot #: 03092016:64@51, Exp.09/07/2016; Lot #: 04142016:01@45, Exp.10/11/2016 04142016:17@37, Exp.10/15/2016; 04282016:72@48, Exp.10/29/2016.
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility