Drug product
UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10
D-0158-2017
Product summary
- Event
- Event 75566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 823 bottles
- Official record key
drug-enforcement:D-0158-2017
Official wording
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Code information: LOT # 29131501, EXP 9/17
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies