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.
Product description
Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
Lot numbers, UPCs & expiration codes
Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019
Where it was sold
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.
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1932-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 3, 2018
- FDA report date
- Sep 12, 2018
- Quantity
- 2209 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VIRTUS PHARMACEUTICALS LLC.
Original FDA data
Every field from FDA enforcement report F-1932-2018, exactly as published.
Show all FDA fields
- City
- Newtown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 80772
- Address
- 12 Penns Trl
- Code information
- Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019
- Postal code
- 18940-1892
- Report date
- Sep 12, 2018
- Product type
- Food
- Recall number
- F-1932-2018
- Classification
- Class III
- Recalling firm
- VIRTUS PHARMACEUTICALS LLC.
- Product quantity
- 2209 Bottles
- Termination date
- Apr 6, 2019
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
- 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.
- Recall initiation date
- Aug 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 4, 2018