FDA-Food2018-09-12Class III

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

VIRTUS PHARMACEUTICALS LLC.
Hazard

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.

Sold states
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, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and West Virginia.
Affected count
11926 Bottles
Manufactured in
12 Penns Trl, N/A, Newtown, PA, United States
Products
Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1933-2018

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