Drug product
Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
D-0504-2020
Product summary
- Event
- Event 84213
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 bottle
- Official record key
drug-enforcement:D-0504-2020
Official wording
Reason: CGMP Deviations: products were not manufactured under current good manufacturing practices.
Code information: Lot #: 101471, Exp 08/01/2020
Distribution pattern: Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Derived failure modes
-
Manufacturing or process control
CGMP Deviations