Drug product
X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
D-0858-2018
Product summary
- Event
- Event 80184
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,252 bottles
- Official record key
drug-enforcement:D-0858-2018
Official wording
Reason: CGMP Deviations: products may be contaminated with bacteria.
Code information: All lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations