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VIRTUS PHARMACEUTICALS LLC.
FDA recall F-1932-2018 · Class III · reported 2018-09-12 · Terminated
- Product
- Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
- 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 Equivalents (DFEs) calculated based on the product formulation.
- Quantity
- 2209 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.
- Firm location
- PA, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Letter
- Recall started
- 2018-08-03
- Terminated
- 2019-04-06
- Code info
- Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.