Wonder Freeze Pain Releiving Gel with ILEX recalled over manufacturing violations

Recall date

July 11, 2019

Source

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

Official notice title

US Pharmaceuticals Inc. recalls Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113…

Recall number

D-1740-2019

FDA classification

Class II

Brand / firm

US Pharmaceuticals Inc.

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

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

What was recalled

Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.