Drug product
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
D-0162-2017
Product summary
- Event
- Event 75566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,149 bottles
- Official record key
drug-enforcement:D-0162-2017
Official wording
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies