AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sod...
FDA Recall #D-0159-2017 — Class II — October 24, 2016
Product Description
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
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
604 bottles
Distribution
Nationwide
Code Information
LOT # 29421501, EXP 10/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated