FDAFDA · Food and drugs·Recall number D-0161-2017
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
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 #: 28161601, EXP 1/18; 28161603, EXP 5/18; and 28161604, EXP 6/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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