UROPHEN MB URINARY ANTISEPTIC Tablets recalled over manufacturing violations

Recall date

October 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Burel Pharmaceuticals Inc recalls UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylat…

Recall number

D-0158-2017

FDA classification

Class II

Brand / firm

Burel Pharmaceuticals Inc

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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