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

FDA recall notice · announced September 12, 2018 · Virtus Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

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 information: Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019
Quantity: 2209 Bottles
Status: Terminated
Products in this recall event:
- Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle (F-1933-2018)
- Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle (F-1932-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.