FDA Drug Recalls

Recalls / Class III

Class IIID-0239-2017

Product

Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30

Affected lot / code info
Lots #: 21511137 Exp. date 10/30/2017

Why it was recalled

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

Recalling firm

Firm
VIRTUS PHARMACEUTICALS OPCO II L
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1321 Murfreesboro Pike #, N/A, Nashville, Tennessee 37217-2726

Distribution

Quantity
2,406 bottles
Distribution pattern
Nationwide

Timeline

Recall initiated
2016-12-12
FDA classified
2016-12-28
Posted by FDA
2017-01-04
Terminated
2018-08-21
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0239-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls