D-0162-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 7, 2016
- Initiation Date
- October 24, 2016
- Termination Date
- August 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,149 bottles
Product Description
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Reason for Recall
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Distribution Pattern
Nationwide
Code Information
Lot #: 28181601, EXP 1/18; 28181603, EXP 5/18; 28181604, EXP 5/18; 28181605, EXP 5/18; 28181606, EXP 6/18; 28181607, EXP 5/18