The Recall Desk
LowFDA (Drugs)·D-0239-2017·Announced 2017-01-04

Virtus Pharmaceuticals Recalls Extra-Virt Plus DHA Prenatal Softgels

Virtus Pharmaceuticals is recalling 2,406 bottles of Extra-Virt Plus DHA Prenatal/Postnatal Softgels because the API manufacturer is on FDA Import Alert.

What this means for you

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

Our severity reasoning: The FDA classified this recall as 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 2,406 bottles of Extra-Virt Plus DHA Prenatal/Postnatal Softgels, a prescription multivitamin/mineral dietary supplement with fish-based DHA. The product is packaged in 30-count bottles and is identified by NDC 76439-251-30. The specific lot affected is 21511137, with an expiration date of 10/30/2017.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the Active Pharmaceutical Ingredient (API) manufacturer is currently on FDA Import Alert. The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recall details, it should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.

The recalled product

Product
Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30
Manufacturer
VIRTUS PHARMACEUTICALS OPCO II L
Category
Drug — Dietary Supplement
Hazard
Affected units
2,406

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 #: 21511137 Exp. date 10/30/2017

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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Same hazard · cGMP deviation

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