Burel Pharmaceuticals Inc recalls Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Pho
Recalled December 7, 2016 · FDA recall D-0160-2017 · Burel Pharmaceuticals
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures · FDA Class II
Units
795 bottles
Sold at
Nationwide
Description
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Product
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
Manufacturer(s)
Burel Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →