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F-1933-2018 Class III Terminated

Recalled by VIRTUS PHARMACEUTICALS LLC. — Newtown, PA

FDA food recall F-1933-2018 was initiated by VIRTUS PHARMACEUTICALS LLC. on August 3, 2018 and is designated Class III. 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 Dietar… The recall status is terminated (terminated April 6, 2019). Affected quantity: 11926 Bottles.

Recall Details

Product Type: Food
Report Date: September 12, 2018
Initiation Date: August 3, 2018
Termination Date: April 6, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11926 Bottles

Product Description

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.

Distribution Pattern

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.

Code Information

Lot# M187380 Expiration Date: 1/2019 Lot# M192410 Expiration Date: 6/2019 Lot# M192410A Expiration Date: 6/2019

Other recalls by VIRTUS PHARMACEUTICALS LLC.

F-1932-2018 Class III — Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 T (August 3, 2018)
D-1048-2016 Class III — VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx (May 16, 2016)
D-1044-2016 Class III — Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, (May 13, 2016)
D-0775-2016 Class III — Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, (January 15, 2016)
D-0801-2016 Class III — VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Suppleme (December 17, 2015)