Drug product
PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-1004-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-1004-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 01282016:60@3, Exp.04/28/2016; Lot #: 02242016: 90@20, Exp.05/24/2016; Lot #: 02222016:06@67, Exp. 05/24/2016; Lot #: 03082016:81@21, Exp.06/06/2016; Lot #: 03162016: 62@1, Exp. 06/14/2016.
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility