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Burel Pharmaceuticals

8 recalls •

• Categories: Prescription Drugs

Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10

Class I - Dangerous

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Oct 24, 2016 Prescription Drugs Nationwide View Details →

AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10

Class I - Dangerous

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Oct 24, 2016 Prescription Drugs Nationwide View Details →

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10

Class I - Dangerous

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Oct 24, 2016 Prescription Drugs Nationwide View Details →

URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10

Class I - Dangerous

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Oct 24, 2016 Prescription Drugs Nationwide View Details →

Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90

Class I - Dangerous

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Oct 24, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Oct 24, 2016 Prescription Drugs Nationwide View Details →

UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10

Class I - Dangerous

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Oct 24, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Oct 24, 2016 Prescription Drugs Nationwide View Details →