Drug recall D-0471-2022
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
Reason for recall
cGMP deviations
Lots and codes
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
Recall details
- Recalling firm
- Ultra Seal Corporation, New Paltz, NY
- Quantity
- a) 702,240 blisters, b) 30,180 blisters
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 24, 2022
- Terminated
- October 16, 2023
Related products
- Cystex – drug information
- NDC 69693-512 Cystex Plus · Methenamine 162 mg/1; Sodium Salicylate 162.5 mg/1 · Clarion Brands, LLC