FDA recall D-1487-2020

Product

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

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-1487-2020