Drug product
Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
D-1092-2023
Product summary
- Event
- Event 92786
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40
- Official record key
drug-enforcement:D-1092-2023
Official wording
Reason: CGMP Deviations
Code information: Lot #: a) J1121010, Exp. Date 12/16/2023, b) A0921006, Exp. Date 8/16/2023, c) A0921007, Exp. Date 8/16/2023
Distribution pattern: Nationwide within the United States, Singapore, Korea and Hong Kong
Derived failure modes
-
Manufacturing or process control
CGMP Deviations