Drug product
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
D-0155-2017
Product summary
- Event
- Event 75566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2861 bottles
- Official record key
drug-enforcement:D-0155-2017
Official wording
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Code information: LOT # 29001501, EXP 07/17
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies