Drug product
Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64195 8.
D-0497-2020
Product summary
- Event
- Event 84213
- Status
- Terminated
- Classification
- Class II
- Quantity
- 417 bottles
- Official record key
drug-enforcement:D-0497-2020
Official wording
Reason: CGMP Deviations: products were not manufactured under current good manufacturing practices.
Code information: Lot #: BR18B272
Distribution pattern: Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Derived failure modes
-
Manufacturing or process control
CGMP Deviations