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Recall Observatory FDA recall evidence

Food product

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

F-1933-2018

August 03, 2018

Class III

Product summary

Firm
VIRTUS PHARMACEUTICALS LLC.
Event
Event 80772
Status
Terminated
Classification
Class III
Quantity
11926 Bottles
Official record key
food-enforcement:F-1933-2018

Official wording

Reason: 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.

Code information: Lot# M187380 Expiration Date: 1/2019 Lot# M192410 Expiration Date: 6/2019 Lot# M192410A Expiration Date: 6/2019

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.