Cystex Urinary Pan Relief packaged in a) blisters and b) blisters recalled over manufacturing violations

Recall date

January 24, 2022

Source

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

Official notice title

Ultra Seal Corporation recalls Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count bliste…

Recall number

D-0471-2022

FDA classification

Class II

Brand / firm

Ultra Seal Corporation

Sold / distributed

Nationwide within the United States

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

Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count blisters, Distributed by: Clarion Brands, LLC 27070 Miles Road, Suite A Solon, OH 44139, NDC 69693-512-40