PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 30, 2023 Initiated: August 2, 2023 #D-1091-2023

Product Description

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

Details

Recalling Firm
Parker Laboratories, Inc.
Units Affected
8
Distribution
Nationwide within the United States, Singapore, Korea and Hong Kong
Location
Fairfield, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Parker Laboratories, Inc.. Units affected: 8.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on August 30, 2023. Severity: Moderate. Recall number: D-1091-2023.