Drug product
FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6.
D-0066-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,109 cans
- Official record key
drug-enforcement:D-0066-2019
Official wording
Reason: Superpotent Drug: high out of specification assay results for the camphor ingredient.
Code information: Lot: 170498B, Exp. 02/23/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Superpotent