Exact FDA event identifier

Event 80772

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 03, 2018
Product types: Food
Classifications: Class III
Statuses: Terminated
Recalling firm wording: VIRTUS PHARMACEUTICALS LLC.

Dossier provenance

Source snapshots represented here

openFDA Food Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

food · product 1 of 2

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

F-1932-2018

Recall number: F-1932-2018
Initiated: August 03, 2018
Classification: Class III
Status: Terminated
Recalling firm: VIRTUS PHARMACEUTICALS LLC.
Quantity: 2209 Bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

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

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.

food · product 2 of 2

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

F-1933-2018

Recall number: F-1933-2018
Initiated: August 03, 2018
Classification: Class III
Status: Terminated
Recalling firm: VIRTUS PHARMACEUTICALS LLC.
Quantity: 11926 Bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Code information

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