D-0471-2022 Class II Terminated
FDA drug recall D-0471-2022 was initiated by Ultra Seal Corporation on Jan 24, 2022 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated Oct 16, 2023). Affected quantity: a) 702,240 blisters, b) 30,180 blisters.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 9, 2022
- Initiation Date
- Jan 24, 2022
- Termination Date
- Oct 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 702,240 blisters, b) 30,180 blisters
Product Description
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
Distribution Pattern
Nationwide within the United States
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0471-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026