LOW RISK Terminated F-1933-2018

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

Recalled by VIRTUS PHARMACEUTICALS LLC.

Classification

Class III — Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.

Reason for Recall

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.

Product Details

Product Quantity

11926 Bottles

Product Type

Food

Code Info

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

Voluntary/Mandated

Voluntary: Firm initiated

Distribution & Geography

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.

Company Location

Newtown, PA, 18940-1892

Timeline

Report Date

09/12/2018

Recall Initiated

08/03/2018

Classification Date

09/04/2018

Termination Date

04/06/2019

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 28, 2026

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