FDA recall D-1092-2023

Parker Laboratories, Inc. · Class II · 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

Reason for recall

CGMP Deviations

Distribution

Nationwide within the United States, Singapore, Korea and Hong Kong

Key facts

Status: Terminated
Initiation date: 2023-08-02
Report date: 2023-08-30
Termination date: 2024-06-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1092-2023