Burel Pharmaceuticals recalls
Burel Pharmaceuticals appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2016-12-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2016-12-07 |
| By agency | FDA Drug (8) |
| By classification | Class II (8) |
| By status | terminated (8) |
| Distribution named in notices | US |
Recalls
- Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Meth…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures - Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methyle…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures - AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures - UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene B…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures - Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures - URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures - Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures - UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl…
FDA Drug · Class II · 2016-12-07 · Burel Pharmaceuticals
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures