FDA recall D-1488-2020

Product

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

Nationwide within the US

Key facts

Status

Terminated

Initiation date

2020-07-24

Report date

2020-08-12

Termination date

2022-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chester Springs, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1488-2020