Drug product
Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
D-1093-2023
Product summary
- Event
- Event 92786
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50
- Official record key
drug-enforcement:D-1093-2023
Official wording
Reason: CGMP Deviations
Code information: Lot #: a) J1121011, Exp. Date 12/21/2023, b) A0921009, Exp. Date 8/18/2023, c) A0921008, Exp. Date 8/18/2023
Distribution pattern: Nationwide within the United States, Singapore, Korea and Hong Kong
Derived failure modes
-
Manufacturing or process control
CGMP Deviations