The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0238-2017·Announced 2017-01-04

Virt-Advance Prenatal Softgels Recalled Due to API Manufacturer Import Alert

Virtus Pharmaceuticals is recalling Virt-Advance Prenatal/Postnatal Softgels because the active ingredient manufacturer is on an FDA Import Alert.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Virtus Pharmaceuticals OPCO II L is recalling Virt-Advance Prenatal/Postnatal Softgels, a prescription folic acid-containing dietary supplement. The product is packaged in 90-count bottles and is distributed nationwide. The recall involves 2,537 bottles with lot numbers 41505136 (expiration date 5/30/2017) and 41605134 (expiration date 4/30/2018).

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the manufacturer of the Active Pharmaceutical Ingredient (API) is currently on an FDA Import Alert. This classification indicates that the agency has identified potential quality or safety issues with the supplier.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, which indicates that the product is not likely to cause adverse health consequences.

The recalled product

Product
Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90
Manufacturer
VIRTUS PHARMACEUTICALS OPCO II L
Category
Drug — Dietary Supplement
Hazard
Affected units
2,537

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lots #: 41505136 Exp. Date 5/30/2017 and 41605134 Exp. date 4/30/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by VIRTUS PHARMACEUTICALS OPCO II L under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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