FDA (Drugs) recall action 75566

Burel Pharmaceuticals Inc recalled 8 products on 2016-12-07

The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2016-12-07
Critical: 0
Units: 72,330

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

ModerateFDA (Drugs)··2016-12-07
Burel Pharmaceuticals Recalls AZUPHEN MB Urinary Antiseptic Capsules
Burel Pharmaceuticals is recalling AZUPHEN MB Urinary Antiseptic Capsules due to manufacturing deviations that may cause assay or content uniformity failures.
Product
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 -
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0 states
ModerateFDA (Drugs)··2016-12-07
Burel Pharmaceuticals Recalls Indiomin MB Capsules Due to Manufacturing Deficiencies
Burel Pharmaceuticals is recalling 795 bottles of Indiomin MB capsules due to manufacturing deviations that may cause assay or content uniformity failures.
Product
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
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0 states
ModerateFDA (Drugs)··2016-12-07
Burel Pharmaceuticals Recalls Phenazopyridine Hydrochloride Tablets Due to Manufacturing Deficiencies
Burel Pharmaceuticals is recalling specific lots of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may result in assay or content uniformity failures.
Product
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
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0 states
ModerateFDA (Drugs)··2016-12-07
Burel Pharmaceuticals Recalls Uramit MB Urinary Antiseptic Capsules
Burel Pharmaceuticals is recalling Uramit MB Urinary Antiseptic Capsules due to manufacturing deviations that may cause assay or content uniformity failures.
Product
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 --
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0 states
ModerateFDA (Drugs)··2016-12-07
Burel Pharmaceuticals Recalls UROLET MB Tablets Due to Manufacturing Deficiencies
Burel Pharmaceuticals is recalling UROLET MB Urinary Antiseptic tablets because manufacturing deficiencies may cause the product to fail potency or uniformity tests.
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 3557
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0 states
ModerateFDA (Drugs)··2016-12-07
Burel Pharmaceuticals Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations
Burel Pharmaceuticals is recalling 17,788 bottles of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may cause assay or content uniformity failures.
Product
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
Category
Distribution
0 states
ModerateFDA (Drugs)··2016-12-07
Burel Recalls Hyolev MB Urinary Antiseptic Tablets Due to Manufacturing Deficiencies
Burel Pharmaceuticals is recalling 2,861 bottles of Hyolev MB Urinary Antiseptic Tablets due to manufacturing deviations that may cause assay or content uniformity failures.
Product
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 PHARMACEUT
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0 states
ModerateFDA (Drugs)··2016-12-07
Burel Pharmaceuticals Recalls UROPHEN MB Urinary Antiseptic Tablets
Burel Pharmaceuticals is recalling UROPHEN MB Urinary Antiseptic Tablets due to manufacturing deviations that may cause assay or content uniformity failures.
Product
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 35573-30
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0 states