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
Reported: February 9, 2022 Initiated: January 24, 2022 #D-0471-2022
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
Details
- Recalling Firm
- Ultra Seal Corporation
- Units Affected
- a) 702,240 blisters, b) 30,180 blisters
- Distribution
- Nationwide within the United States
- Location
- New Paltz, NY
Frequently Asked Questions
What product 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. Recalled by Ultra Seal Corporation. Units affected: a) 702,240 blisters, b) 30,180 blisters.
Why was this product recalled? ▼
cGMP deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 9, 2022. Severity: Moderate. Recall number: D-0471-2022.
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