Drug product
Calcarea Phosphorica 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 64189 7.
D-0492-2020
Product summary
- Event
- Event 84213
- Status
- Terminated
- Classification
- Class II
- Quantity
- 681 bottles
- Official record key
drug-enforcement:D-0492-2020
Official wording
Reason: CGMP Deviations: products were not manufactured under current good manufacturing practices.
Code information: Lot #: BR18C282 and BR18K166
Distribution pattern: Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
Derived failure modes
-
Manufacturing or process control
CGMP Deviations