UROLET MB URINARY ANTISEPTIC 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 UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosph…

Recall number

D-0156-2017

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

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