Food recall: Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
Class III FDA enforcement event 80772. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
VIRTUS PHARMACEUTICALS LLC. started this food recall on 3 Aug 2018. The firm address in the FDA record is in Newtown, PA. FDA put the recall in Class III. FDA event 80772 has 2 product records. The first FDA enforcement report date is 12 Sep 2018. The record gives the status Terminated, with the termination date 6 Apr 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Virt Nate: Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Vermont and Wisconsin. Virt Gard:…
Recalling firm
VIRTUS PHARMACEUTICALS LLC., Newtown, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-1932-2018 | Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle | 2209 Bottles | Class III | Terminated | 12 Sep 2018 |
| F-1933-2018 | Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle | 11926 Bottles | Class III | Terminated | 12 Sep 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Food events that started in 2018
- 578
- Share of these events in Class III
- 10%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 May 2016 | VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceu | Drug | Class III | 1 |
| 13 May 2016 | Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharm | Drug | Class III | 1 |
| 15 Jan 2016 | Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For | Drug | Class III | 1 |
| 17 Dec 2015 | VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufa | Drug | Class III | 1 |
Official channels
- FDA enforcement report F-1932-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 80772. https://recallregister.com/fda/iii/80772/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Virt Nate: Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Vermont and Wisconsin. Virt Gard:…
- What quantity of product is in FDA event 80772?
- The event has 2 product records. The first record gives this quantity:
2209 Bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2018 have the same class?
- 10% of the 578 food events that started in 2018 are in Class III.