Screamin' menthol Pain Relieving Gel recalled over manufacturing violations

Recall date

May 16, 2018

Source

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

Official notice title

Ideaz Llc recalls screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141…

Recall number

D-0835-2018

FDA classification

Class II

Brand / firm

Ideaz Llc

Sold / distributed

Nationwide in the U.S.A.

Why it was recalled

CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.

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

What was recalled

screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.