D-1488-2020 Class II Terminated
FDA drug recall D-1488-2020 was initiated by Vilvet Pharmaceuticals Inc. on Jul 24, 2020 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated Jan 21, 2022). Affected quantity: 1,716 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 12, 2020
- Initiation Date
- Jul 24, 2020
- Termination Date
- Jan 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1488-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026