Class III · Low riskTerminated Initiated Aug 3, 2018 (8 years ago)
Virt Gard Tablets recall
Recalled by Virtus Pharmaceuticals LLC. · Newtown, PA, United States
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
A label that does not match the product can hide an ingredient someone must avoid, or show a wrong use-by date. All labeling errors recalls.
What was recalled
Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
ArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKentuckyMassachusettsMichiganMinnesotaMissouriMississippiNorth CarolinaNew JerseyNew YorkOhioOklahomaPennsylvaniaSouth CarolinaTexasVirginiaVermontWisconsinWest Virginia
FDA's distribution note: 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.
Low risk, but check. Class III means the product is unlikely to make anyone ill but breaks an FDA rule, often a labeling one. If your package matches, the store will normally refund it. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.
Reason 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…