FDA recall D-0238-2017

VIRTUS PHARMACEUTICALS OPCO II L · Class III · drug

Product

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-12-12
Report date: 2017-01-04
Termination date: 2018-08-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Nashville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0238-2017