Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, ...

FDA Recall #D-0238-2017 — Class III — December 12, 2016

Recall #D-0238-2017 Date: December 12, 2016 Classification: Class III Status: Terminated

Product Description

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

Reason for Recall

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Recalling Firm

VIRTUS PHARMACEUTICALS OPCO II L — Nashville, TN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

2,537 bottles

Distribution

Nationwide

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated