Product: UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains:  Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS
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