Drug product
Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
D-1091-2023
Product summary
- Event
- Event 92786
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
drug-enforcement:D-1091-2023
Official wording
Reason: CGMP Deviations
Code information: Lot #: a) A1221010, Exp. Date 12/9/2023, b) A1221011, Exp date 12/9/2023
Distribution pattern: Nationwide within the United States, Singapore, Korea and Hong Kong
Derived failure modes
-
Manufacturing or process control
CGMP Deviations