Class II · Moderate risk Terminated
Cystex Tablet
Reason CGMP Deviations
Cystex Urinary Pan Relief
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
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
- Recalling firm
- Ultra Seal Corporation
- NDC code
- 69693-512-40
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0471-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Methenamine recalls
See all
Class II · Moderate risk Terminated
VILEVEV MB Urinary Antispetic
Reason cGMP deviations
Class II · Moderate risk Terminated
Vilamit Mb
Reason cGMP deviations
Class II · Moderate risk Terminated
Urin D/S Tablets Methenamine 81.6 mg
Reason Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Class II · Moderate risk Terminated
Indiomin MB URINARY ANTISEPTIC
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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