Cystex Urinary Pain Relief (Ultra Seal) - Manufacturing Deviation (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Ultra Seal Corporation
Lot Codes / Batch Numbers
Lot #: a) 19A043, 19A093, Exp. Date 01/2022, 19B062, 19C079, 19C080, Exp. Date 03/2022, 19D041, Exp. Date 04/2022, 19E035, 19E087, Exp. Date 05/2022, 19G084, Exp. Date 08/2022, 19H098, Exp. Date 09/2022 b) 19H098A, Exp. Date 09/2022
Products Sold
Lot #: a) 19A043, 19A093, Exp. Date 01/2022; 19B062,19C079,19C080, Exp. Date 03/2022; 19D041, Exp. Date 04/2022; 19E035, 19E087, Exp. Date 05/2022; 19G084, Exp. Date 08/2022; 19H098, Exp. Date 09/2022 b) 19H098A, Exp. Date 09/2022
Ultra Seal Corporation is recalling Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in due to cGMP deviations. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP deviations
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026