Drug product
M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-0995-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-0995-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 01222016:57@21, Exp.03/33/2016; Lot #: 01222016: 78@51, Exp.04/25/2016; Lot #: 01272016:51@23, Exp. 03/27/2016; Lot #: 02292016:71@13, Exp. 04/29/2016; Lot #: 03022016:46@14, Exp. 06/22/2016; Lot #:04252016:20@62, Exp.06/24/2016; Lot #: 04262016:18@11, Exp.06/25/2016
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility