Home / Brands / Burel Pharmaceuticals
Burel Pharmaceuticals Recalls
8 recalls on record · December 7, 2016 to December 7, 2016 · Drugs
December 7, 2016DrugsFDA
Burel Pharmaceuticals Inc recalls Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals,
Hazard: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
December 7, 2016DrugsFDA
Burel Pharmaceuticals Inc recalls Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals,
Hazard: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
December 7, 2016DrugsFDA
Burel Pharmaceuticals Inc recalls Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Pho
Hazard: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
December 7, 2016DrugsFDA
Burel Pharmaceuticals Inc recalls AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg,
Hazard: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
December 7, 2016DrugsFDA
Burel Pharmaceuticals Inc recalls UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylat
Hazard: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
December 7, 2016DrugsFDA
Burel Pharmaceuticals Inc recalls URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, P
Hazard: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
December 7, 2016DrugsFDA
Burel Pharmaceuticals Inc recalls UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosph
Hazard: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
December 7, 2016DrugsFDA
Burel Pharmaceuticals Inc recalls Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methena
Hazard: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures