URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodi...
FDA Recall #D-0157-2017 — Class II — October 24, 2016
Product Description
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
Reason for Recall
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recalling Firm
Burel Pharmaceuticals Inc — Richland, MS
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,771 bottles
Distribution
Nationwide
Code Information
LOT # 28751601, exp 8/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated