D-0238-2017 Class III Terminated
FDA drug recall D-0238-2017 was initiated by VIRTUS PHARMACEUTICALS OPCO II L on December 12, 2016 and is designated Class III. Reason for recall: cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. The recall status is terminated (terminated August 21, 2018). Affected quantity: 2,537 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 4, 2017
- Initiation Date
- December 12, 2016
- Termination Date
- August 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,537 bottles
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.
Distribution Pattern
Nationwide
Code Information
Lots #: 41505136 Exp. Date 5/30/2017 and 41605134 Exp. date 4/30/2018