F-1933-2018 Class III Terminated

Recalled by VIRTUS PHARMACEUTICALS LLC. — Newtown, PA

Recall Details

Product Type
Food
Report Date
September 12, 2018
Initiation Date
August 3, 2018
Termination Date
April 6, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11926 Bottles

Product Description

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

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.

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.

Code Information

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