FDA-Drug2016-12-07Class II
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
Burel Pharmaceuticals Inc
Hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Sold states
Nationwide
Affected count
2,771 bottles
Manufactured in
199 Interstate Dr Ste N, Richland, MS, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0157-2017Don't want to check this manually?
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