D-1487-2020 Class II Terminated
FDA drug recall D-1487-2020 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: 11,640 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
- 11,640 bottles
Product Description
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.
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the US
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1487-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026