Indiomin 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 Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Pho…

Recall number

D-0160-2017

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

Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10