Burel Pharmaceuticals Inc recalls UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosph
Recalled December 7, 2016 · FDA recall D-0156-2017 · Burel Pharmaceuticals
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures · FDA Class II
Units
11,539 bottles
Sold at
Nationwide
Description
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Product
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
Manufacturer(s)
Burel Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →