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Recall Observatory FDA recall evidence

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

August 02, 2023

Class II

Product summary

Firm
Parker Laboratories, Inc.
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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations