VIRTUS PHARMACEUTICALS OPCO II L: cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Agency Publication Date: December 28, 2016

Affected Products

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

Lots #: 41505136 Exp. Date 5/30/2017 and 41605134 Exp. date 4/30/2018

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

Lots #: 21511137 Exp. date 10/30/2017

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

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

Product: 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

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76103

Status: Resolved

Manufacturer: VIRTUS PHARMACEUTICALS OPCO II L

Manufactured In: United States

Units Affected: 4 products (2,537 bottles; 2,406 bottles; 9,795 bottles; 124,250 bottles)

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Sources: FDA iRES · Raw API Response

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