Helix Pain Relieving Cream recalled over manufacturing violations

Recall date

August 2, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Parker Laboratories, Inc. recalls Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 3077…

Recall number

D-1090-2023

FDA classification

Class II

Brand / firm

Parker Laboratories, Inc.

Sold / distributed

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

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004