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Recall Observatory FDA recall evidence

Drug product

Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30

D-0240-2017

December 12, 2016

Class III

Product summary

Firm
VIRTUS PHARMACEUTICALS OPCO II L
Event
Event 76103
Status
Terminated
Classification
Class III
Quantity
9,795 bottles
Official record key
drug-enforcement:D-0240-2017

Official wording

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

Code information: Lots #: 21511153 Exp. date 10/30/2017

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations