FDAFDA · Food and drugs·Recall number D-0159-2017
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
Published December 7, 2016 · Recall initiated: October 24, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Burel Pharmaceuticals Inc
- Distributor
- Nationwide
- Lot
- LOT # 29421501, EXP 10/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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