Drug product
VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-1023-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-1023-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 01120J67: 6@22, Exp. 04/12/2016; Lot #: 021820J6 : 52@39, Exp.04/18/2016; Lot #: 02262016: 89@3, Exp. 04/26/2016; Lot #: 03082016 : 76@46 06/06/2016;03022016:61@8, Exp. 06/08/2016; 032120 16:49@65, Exp.06/21/2016; 01152016:48@14, Exp. 04/19/2016; 03032016:74@52, Exp. 05/02/2016; 03242016:68@13, Exp. 06/27/2016; 04142016:00@50, Exp. 06/13/2016.
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility