D-1488-2020 Class II Terminated
FDA drug recall D-1488-2020 was initiated by Vilvet Pharmaceuticals Inc. on July 24, 2020 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated January 21, 2022). Affected quantity: 1,716 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 12, 2020
- Initiation Date
- July 24, 2020
- Termination Date
- January 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,716 bottles
Product Description
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.
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the US
Code Information
LOT M823J18-1, M823J18-2, M823J18-3 EXP 09/20; LOT M823D19-1 EXP 04/21