FDAFDA · Food and drugs·Recall number D-0157-2017
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
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 # 28751601, exp 8/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.