Food Recall Check
Class III · Low risk Terminated Initiated Aug 3, 2018 (8 years ago)

Virt-Nate Tablets Number of units per package recall

Recalled by Virtus Pharmaceuticals LLC. · Newtown, PA, United States

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

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.

A label that does not match the product can hide an ingredient someone must avoid, or show a wrong use-by date. All labeling errors recalls.

What was recalled

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

Quantity: 2209 Bottles

Food: Dietary supplements

Lot codes, dates and UPCs

A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.

Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019

Where it was sold

Arizona California Colorado Florida Georgia Iowa Illinois Indiana Kentucky Massachusetts Michigan Minnesota Missouri Mississippi North Carolina New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Texas Virginia Vermont Wisconsin West Virginia

FDA's distribution note: 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.

Low risk, but check. Class III means the product is unlikely to make anyone ill but breaks an FDA rule, often a labeling one. If your package matches, the store will normally refund it. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.

Recalling firm
Virtus Pharmaceuticals LLC.
Initiated by
Voluntary: Firm initiated
Recall initiated
Aug 3, 2018
In FDA report of
Sep 12, 2018
Terminated
Apr 6, 2019
FDA recall number
F-1932-2018 · event 80772
Official record
FDA enforcement report search

Also recalled with it (1 more product)

FDA files each product of one recall action separately; these share the same FDA event.

Class III · Low risk Terminated Labeling

Virt Gard Tablets

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…

Virtus Pharmaceuticals LLC. 26 states F-1933-2018

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