Home / VIRTUS PHARMACEUTICALS LLC. / F-1933-2018
Class III
VIRTUS PHARMACEUTICALS LLC.
Recall #F-1933-2018 · Initiated 2018-08-03
Product
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.
Quantity affected
11926 Bottles
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.
Lot / 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
Initial notification
Letter
Terminated
2019-04-06
Recalling firm
VIRTUS PHARMACEUTICALS LLC.
12 Penns Trl
Newtown, PA 18940-1892
United States
Recall classification
Unlikely to cause any adverse health consequences.