FDA recall D-1091-2023

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

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-1091-2023