Drug product
SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-1009-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-1009-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 01062016:29@49, Exp.04/06/2016; Lot #: 02032016: 30@5, Exp.05/03/2016; Lot #: 03312016:91@17; Exp. 06/29/2016; Lot #: 03302016:17@40, Exp. 06/30/2016; Lot 4132016:46@20, Exp. 07/12/2016.
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility