Drug product
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
D-0161-2017
Product summary
- Event
- Event 75566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,788 bottles
- Official record key
drug-enforcement:D-0161-2017
Official wording
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Code information: Lot #: 28161601, EXP 1/18; 28161603, EXP 5/18; and 28161604, EXP 6/18
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies