FDAFDA · Food and drugs·Recall number D-0155-2017
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
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 # 29001501, EXP 07/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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