Drug product
R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
D-0506-2020
Product summary
- Event
- Event 84213
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1 bottle; b) 11 bottles
- Official record key
drug-enforcement:D-0506-2020
Official wording
Reason: CGMP Deviations: products were not manufactured under current good manufacturing practices.
Code information: Lot #: 28557
Distribution pattern: Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Derived failure modes
-
Manufacturing or process control
CGMP Deviations