Ultra Seal Corporation: Drug Recall
Recall #D-0471-2022 · 01/24/2022
Class II: Risk
Recall Details
- Recall Number
- D-0471-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Ultra Seal Corporation
- Status
- Terminated
- Date Initiated
- 01/24/2022
- Location
- New Paltz, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 702,240 blisters, b) 30,180 blisters
Reason for Recall
cGMP deviations
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
Distribution Pattern
Nationwide within the United States
Other Recalls by Ultra Seal Corporation
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.