Burel Pharmaceuticals recalls
FDA enforcement reports naming Burel Pharmaceuticals Inc as the recalling firm.
- Recall reports
- 8
- Class I (serious)
- 0
- Most recent report
- Dec 7, 2016
- Dec 7, 2016Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyo…Drug · Burel Pharmaceuticals IncCGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failuresClass II
- Dec 7, 2016UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81Drug · Burel Pharmaceuticals IncCGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failuresClass II
- Dec 7, 2016URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Mono…Drug · Burel Pharmaceuticals IncCGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failuresClass II
- Dec 7, 2016UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81Drug · Burel Pharmaceuticals IncCGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failuresClass II
- Dec 7, 2016AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Mon…Drug · Burel Pharmaceuticals IncCGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failuresClass II
- Dec 7, 2016Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methena…Drug · Burel Pharmaceuticals IncCGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failuresClass II
- Dec 7, 2016Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufac…Drug · Burel Pharmaceuticals IncCGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failuresClass II
- Dec 7, 2016Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufac…Drug · Burel Pharmaceuticals IncCGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failuresClass II