FDA-Drug2016-12-07Class II
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
Burel Pharmaceuticals Inc
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Sold states
Nationwide
Affected count
2861 bottles
Manufactured in
199 Interstate Dr Ste N, Richland, MS, United States
Products
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2017Don't want to check this manually?
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