Burel Pharmaceuticals Inc recalls AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg,
Recalled December 7, 2016 · FDA recall D-0159-2017 · Burel Pharmaceuticals
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures · FDA Class II
Units
604 bottles
Sold at
Nationwide
Description
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Product
AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10
Manufacturer(s)
Burel Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →