Class IIIFDA3 Aug 2018F-1932-2018

VIRTUS PHARMACEUTICALS LLC. recalls Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bott (Class III)

Class III — Eating this product is not likely to cause health problems, but it violates FDA labelling or manufacturing rules.

Product

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

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

Reason for recall

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.

Affected products (2)

Recall #	Product	Lot / code	Status
F-1932-2018	Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle	Lot# M185860 Expiration Date: 12/2018 Lot# M1903000 Expiration Date: 4/2019	Terminated
F-1933-2018	Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle	Lot# M187380 Expiration Date: 1/2019 Lot# M192410 Expiration Date: 6/2019 Lot# M192410A Expiration Date: 6/2019	Terminated

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