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FDAFDA · Food and drugs·Recall number F-1932-2018

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

Published September 12, 2018 · Recall initiated: August 3, 2018

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
VIRTUS PHARMACEUTICALS LLC.
Distributor
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.
Lot
Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019
Risk classification
Class III
Area (FDA)
food
Country
United States

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