Multi-event December 2016 FDA Recall Drug by Virtus Pharmaceuticals Opco Ii L

This Multi-event Class III drug recall was voluntarily initiated by Virtus Pharmaceuticals Opco Ii L on December 12, 2016 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0240-2017 TERMINATED D-0238-2017 TERMINATED D-0241-2017 TERMINATED D-0239-2017 TERMINATED

Recall Number: D-0240-2017

Reason for Recall
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Initiated
12-12-2016
Reported
01-04-2017
Quantity
9,795 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76103
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
VIRTUS PHARMACEUTICALS OPCO II L
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-21-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-0238-2017

Reason for Recall
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Initiated
12-12-2016
Reported
01-04-2017
Quantity
2,537 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76103
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
VIRTUS PHARMACEUTICALS OPCO II L
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-21-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-0241-2017

Reason for Recall
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Initiated
12-12-2016
Reported
01-04-2017
Quantity
124,250 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76103
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
VIRTUS PHARMACEUTICALS OPCO II L
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-21-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-0239-2017

Reason for Recall
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Initiated
12-12-2016
Reported
01-04-2017
Quantity
2,406 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76103
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
VIRTUS PHARMACEUTICALS OPCO II L
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-21-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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