Virtus Pharmaceuticals Recalls Virt-Nate and Virt Gard Tablets for Labeling Error
Virtus Pharmaceuticals is recalling Virt-Nate and Virt Gard tablets because the labels do not reflect the correct amount of Dietary Folate Equivalents.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a labeling error regarding the amount of Dietary Folate Equivalents, which fits the criteria for minor labeling errors.
Plain-English summary
Virtus Pharmaceuticals, LLC has initiated a recall of Virt-Nate Tablets and Virt Gard Tablets. The recall was initiated because the product labels do not reflect the correct amount of Dietary Folate Equivalents (DFEs) calculated based on the product formulation.
The affected products are packaged in bottles of 100 tablets. The recall includes specific lots with expiration dates of January 2019 and June 2019. The products were distributed to various states across the United States, including Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Vermont, Virginia, West Virginia, and Wisconsin.
Consumers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If they possess the affected products, they should stop using them and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
- Manufacturer
- VIRTUS PHARMACEUTICALS LLC.
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 11,926
Distribution
Part of a larger recall action
This product is one of 2 recalled by VIRTUS PHARMACEUTICALS LLC. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · VIRTUS PHARMACEUTICALS LLC.
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