Drug product
GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
D-0986-2016
Product summary
- Event
- Event 74187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 Units (Total All Products)
- Official record key
drug-enforcement:D-0986-2016
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Code information: Lot #: 02222016:97@38, Exp.05/24/2016; Lot #: 03032016:27@26 , Exp. 06/26/2016; Lot #: 4272016:60@37, Exp. 07/26/2016; Lot #: 01132016:18@44, Exp. 02/03/2016; Lot #: 01132016:74 @17, Exp. 03/04/2016; Lot #: 01132016:90@9, Exp. 03/04/2016; Lot #: 02222016:34@23, Exp. 04/03/2016; Lot #: 04282016:79@45, Exp. 06/27/2016
Distribution pattern: NV
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility