FDA Drug recall D-0471-2022
Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count b…
- FDA Drug
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count b… by Ultra Seal, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0471-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-24 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ultra Seal |
| Distribution | US |
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
cGMP deviations
Identifiers
| ndc | 69693-512-40 |
|---|---|
| ndc | 69693-512-20 |
| ndc | 69693-512-24 |
| ndc | 69693-512-48 |
| code_info | Lot #: a) 19A043, 19A093, Exp. Date 01/2022; 19B062,19C079,19C080, Exp. Date 03/2022; 19D041, Exp. Date 04/2022; 19E035…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0471-2022%22
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