FDA-Drug2016-12-07Class II
UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10
Burel Pharmaceuticals Inc
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Sold states
Nationwide
Affected count
823 bottles
Manufactured in
199 Interstate Dr Ste N, Richland, MS, United States
Products
UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0158-2017Don't want to check this manually?
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