Product: 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
Reason for recall: CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures
Recall initiated: 20161024
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated