Class IIITerminated in FDA datasetAug 3, 2018

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

Recalling firm: VIRTUS PHARMACEUTICALS LLC.

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.

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Compare the exact product and package details with the label you have.

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

FDA code information

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

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Full FDA record and distribution details

Original product description

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

Extracted codes and context

TypeCode / valueContext
lotM187380Lot# M187380 Expiration Date: 1/2019 Lot# M192410 Expiration Date: 6/2019 Lot# M192410A Expiration Date: 6/2019
lotM192410Lot# M187380 Expiration Date: 1/2019 Lot# M192410 Expiration Date: 6/2019 Lot# M192410A Expiration Date: 6/2019
lotM192410Aot# M187380 Expiration Date: 1/2019 Lot# M192410 Expiration Date: 6/2019 Lot# M192410A Expiration Date: 6/2019

Recall details

Recall number
F-1933-2018
Event ID
80772
FDA status
Terminated
Initiated
Aug 3, 2018
Reported
Sep 12, 2018
Classified
Sep 4, 2018
Terminated
Apr 6, 2019
Quantity
11926 Bottles
Location
Newtown, PA, United States
Initiation type
Voluntary: Firm initiated
Notification
Letter

Where it was 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, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and West Virginia.

FDA source record · F-1933-2018

Data updated September 16, 2026. View official FDA data ↗

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