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 Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
Lot numbers, UPCs & expiration codes
Lot# M187380 Expiration Date: 1/2019 Lot# M192410 Expiration Date: 6/2019 Lot# M192410A Expiration Date: 6/2019
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-1933-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 3, 2018
- FDA report date
- Sep 12, 2018
- Quantity
- 11926 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VIRTUS PHARMACEUTICALS LLC.
Original FDA data
Every field from FDA enforcement report F-1933-2018, 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# M187380 Expiration Date: 1/2019 Lot# M192410 Expiration Date: 6/2019 Lot# M192410A Expiration Date: 6/2019
- Postal code
- 18940-1892
- Report date
- Sep 12, 2018
- Product type
- Food
- Recall number
- F-1933-2018
- Classification
- Class III
- Recalling firm
- VIRTUS PHARMACEUTICALS LLC.
- Product quantity
- 11926 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 Gard 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