FDAOctober 24, 2016drug

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

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.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →