Virt-Advance Prenatal/Postnatal Softgels recalled over manufacturing violations

Recall date

December 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

VIRTUS PHARMACEUTICALS OPCO II L recalls Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count b…

Recall number

D-0238-2017

FDA classification

Class III

Brand / firm

VIRTUS PHARMACEUTICALS OPCO II L

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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