Key Takeaway

Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle by VIRTUS PHARMACEUTICALS LLC. was recalled on August 3, 2018. The hazard: Virtus Pharmaceuticals, LLC has decided to initiate a recall of the following products : Virt-Nate Tablets and Virt Gard Tablets because product...

FDA Food Class III Terminated

Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle

Recalled: August 3, 2018 ~11926 Bottles units affected F-1933-2018

Description

Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle

Hazard / 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.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle

Food

Company Information

VIRTUS PHARMACEUTICALS LLC.

Newtown, PA, United States

View all 6 recalls by VIRTUS PHARMACEUTICALS LLC. →

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.

Related Recalls

FDA Food Class III

Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle

August 3, 2018
FDA Drug Class III

VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30

May 16, 2016
FDA Drug Class III

Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10

May 13, 2016
FDA Drug Class III

Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL

January 15, 2016
FDA Drug Class III

VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 3

December 17, 2015

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Food. Visit the agency's official website for the original notice.

Data sourced from FDA Food Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.