Recalls / Class II
Class IID-1092-2023
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
- Affected lot / code info
- Lot #: a) J1121010, Exp. Date 12/16/2023, b) A0921006, Exp. Date 8/16/2023, c) A0921007, Exp. Date 8/16/2023
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Parker Laboratories, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 286 Eldridge Rd, N/A, Fairfield, New Jersey 07004-2509
Distribution
- Quantity
- 40
- Distribution pattern
- Nationwide within the United States, Singapore, Korea and Hong Kong
Timeline
- Recall initiated
- 2023-08-02
- FDA classified
- 2023-08-18
- Posted by FDA
- 2023-08-30
- Terminated
- 2024-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1092-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.