FDA-Drug2022-02-09Class II

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

Ultra Seal Corporation
Hazard

cGMP deviations

Sold states
Nationwide within the United States
Affected count
a) 702,240 blisters, b) 30,180 blisters
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0471-2022

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