Reported Sep 12, 2018 · Terminated
Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
Virtus Pharmaceuticals Llc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: VIRTUS PHARMACEUTICALS LLC. · 12 Penns Trl · Newtown, PA · 18940-1892
Is this the product you have?
- Virt-Nate Tablets
- Number of units per package100
- Tablets Package Type100 Tablets/Bottle
- Lot codes and dates
- Lot#
- M185860 Expiration Date12/2018 Lot#
- M1903000 Expiration Date4/2019
- Amount recalled
- 2209 Bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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