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 remote possibility of adverse health consequences. The hazard is a labeling error regarding 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 recall involves 2,209 bottles of Virt-Nate Tablets. The affected products were distributed in Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin. The recall also covers Virt Gard Tablets distributed in 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.
The affected lots include Lot# M185860 with an expiration date of 12/2018 and Lot# M1903000 with an expiration date of 4/2019. Consumers should check their medication for these specific lot numbers and expiration dates. The source text does not specify further consumer actions or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
- Manufacturer
- VIRTUS PHARMACEUTICALS LLC.
- Category
- Drug — Tablets
- Hazard
- Affected units
- 2,209
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019
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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