The Recall Desk
ModerateFDA (Drugs)·D-0240-2017·Announced 2017-01-04

Virtus Pharmaceuticals Recalls Virt-Select Prenatal Softgels Due to GMP Deviations

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

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which typically corresponds to a severity score of 1 or 2. Given the specific mention of cGMP deviations and an Import Alert for the API manufacturer, a score of 2 (Moderate) is appropriate as it reflects a voluntary precautionary measure for a low-risk contamination or manufacturing issue.

Plain-English summary

Virtus Pharmaceuticals OPCO II L is recalling Virt-Select 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 76439-249-30. The recall involves 9,795 bottles from Lot # 21511153, which has an expiration date of 10/30/2017.

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. The product was distributed nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30
Manufacturer
VIRTUS PHARMACEUTICALS OPCO II L
Category
Drug — Dietary Supplement
Hazard
Affected units
9,795

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 #: 21511153 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 manufacturer · VIRTUS PHARMACEUTICALS OPCO II L

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