Drug product
VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425, NDC 71186-000-24.
D-1488-2020
Product summary
- Event
- Event 86069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,716 bottles
- Official record key
drug-enforcement:D-1488-2020
Official wording
Reason: cGMP deviations
Code information: LOT M823J18-1, M823J18-2, M823J18-3 EXP 09/20; LOT M823D19-1 EXP 04/21
Distribution pattern: Nationwide within the US
Derived failure modes
-
Manufacturing or process control
cGMP deviations