D-1488-2020 Class II Terminated

Recalled by Vilvet Pharmaceuticals Inc. — Chester Springs, PA

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