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FDAOctober 24, 2016drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

burel pharmaceuticalsburel

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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