VIRTUS PHARMACEUTICALS LLC. recalls Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle

Recall date

August 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

F-1933-2018

FDA classification

Class III

Brand / firm

VIRTUS PHARMACEUTICALS LLC.

Sold / distributed

Virt Nate: Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Vermont and Wisconsin. Virt Gard: Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Mis…

Why it was recalled

Virtus Pharmaceuticals, LLC has decided to initiate a recall of the following products : Virt-Nate Tablets and Virt Gard Tablets because product labels do not reflect the correct amount of Dietary Folate Equivalents (DFEs) calculated based on the product formulation.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle