Burel Pharmaceuticals Inc recalls UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylat
Recalled December 7, 2016 · FDA recall D-0158-2017 · Burel Pharmaceuticals
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures · FDA Class II
Units
823 bottles
Sold at
Nationwide
Description
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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
Manufacturer(s)
Burel Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →