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Class III: unlikely to cause harmTerminated

Virtus Pharmaceuticals Opco Ii L Virt-Select Prenatal/Postnatal Softgels Recall

Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supp…

VIRTUS PHARMACEUTICALS OPCO II L · Nashville, TN

Risk level
Class III
Reported by FDA
Jan 4, 2017
Recall ID
D-0240-2017
Check your lot numberHow we source this data

Summary

Virtus Pharmaceuticals Opco Ii L recalled Virt-Select Prenatal/Postnatal Softgels starting Dec 12, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0240-2017 on Jan 4, 2017. Reason: cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0240-2017
Classification
Class III
Status
Terminated
Recall initiated
Dec 12, 2016
FDA report date
Jan 4, 2017
Quantity
9,795 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
VIRTUS PHARMACEUTICALS OPCO II L

Original FDA data

Every field from FDA enforcement report D-0240-2017, exactly as published.

Show all FDA fields
City
Nashville
State
TN
Status
Terminated
Country
United States
Event ID
76103
Address
1321 Murfreesboro Pike #
Code information
Lots #: 21511153 Exp. date 10/30/2017
Postal code
37217-2726
Report date
Jan 4, 2017
Product type
Drugs
Recall number
D-0240-2017
Classification
Class III
Recalling firm
VIRTUS PHARMACEUTICALS OPCO II L
Product quantity
9,795 bottles
Termination date
Aug 21, 2018
Reason for recall
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide
Recall initiation date
Dec 12, 2016
Initial firm notification
Letter
Center classification date
Dec 28, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0240-2017, published Jan 4, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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