Drug product
VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35.
D-1487-2020
Product summary
- Event
- Event 86069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,640 bottles
- Official record key
drug-enforcement:D-1487-2020
Official wording
Reason: cGMP deviations
Code information: LOT M824H18-1 EXP 08/20 LOT M824J18-1 EXP 09/20 LOT M824L18-1 EXP 11/20 LOT M824A19-1 EXP 01/21 LOT M824C19-1 EXP 03/21 LOT M824G19-1 EXP 07/21
Distribution pattern: Nationwide within the US
Derived failure modes
-
Manufacturing or process control
cGMP deviations