Drug product
Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10
D-0160-2017
Product summary
- Event
- Event 75566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 795 bottles
- Official record key
drug-enforcement:D-0160-2017
Official wording
Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Code information: LOT # 29401501, EXP 10/17
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies