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Virt-Nate Tablets, Number of units per package: 100 Tablets…: FDA Recall F-1932-2018

Agency action: Aug 3, 2018Record ID: F-1932-2018
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What happened

Original notice title

Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle, recall F-1932-2018

From the archived source record

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 the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Terminated
FDA recall classification
Class III
Recall initiated by
Voluntary: Firm initiated
Report date
Sep 12, 2018
Termination date in the archive
Apr 6, 2019
Source checked
Jul 16, 2026
Record revision
610e32ca0a3d

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
Company
VIRTUS PHARMACEUTICALS LLC.
Lot / identifier
Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019
Market / distribution
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.