Kool Comfort Cooling Pain Relief 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 Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52…

Recall number

D-1739-2019

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

Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.