Product: 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
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