VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packa...
FDA Recall #D-0241-2017 — Class III — December 12, 2016
Product Description
VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30
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
124,250 bottles
Distribution
Nationwide
Code Information
Lots #: 21506124 Exp. Date 5/30/2017, 21511151 Exp. date 10/30/2017, 21511151A Exp. Data 10/30/2017, 21512163 Exp. date 11/30/2017, 21512164 Exp. date 11/30/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated