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Class III: unlikely to cause harmTerminated

Virtus Pharmaceuticals VP-CH-PNV PRENATAL/POSTNATAL Prescription Recall

VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-…

Virtus Pharmaceuticals, Llc · Tampa, FL

Risk level
Class III
Reported by FDA
Apr 13, 2016
Recall ID
D-0801-2016
Check your lot numberHow we source this data

Summary

Virtus Pharmaceuticals recalled VP-CH-PNV PRENATAL/POSTNATAL Prescription starting Dec 17, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0801-2016 on Apr 13, 2016. Reason: Defective Delivery System: Product may contain leaking capsules. Status: Terminated.

Why it was recalled

Defective Delivery System: Product may contain leaking capsules.

Product description

VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305

Lot numbers, UPCs & expiration codes

Lot #21506132; Exp. 05/17

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-0801-2016
Classification
Class III
Status
Terminated
Recall initiated
Dec 17, 2015
FDA report date
Apr 13, 2016
Quantity
688 bottles ( 20,640 softgel capsules)
Recall type
Voluntary: Firm initiated
Recalling firm
Virtus Pharmaceuticals, Llc

Original FDA data

Every field from FDA enforcement report D-0801-2016, exactly as published.

Show all FDA fields
City
Tampa
State
FL
Status
Terminated
Country
United States
Event ID
73295
Address
2649 Causeway Center Dr
Code information
Lot #21506132; Exp. 05/17
Postal code
33619-6102
Report date
Apr 13, 2016
Product type
Drugs
Recall number
D-0801-2016
Classification
Class III
Recalling firm
Virtus Pharmaceuticals, Llc
Product quantity
688 bottles ( 20,640 softgel capsules)
Termination date
Aug 16, 2018
Reason for recall
Defective Delivery System: Product may contain leaking capsules.
Voluntary / mandated
Voluntary: Firm initiated
Product description
VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305
Distribution pattern
Nationwide
Recall initiation date
Dec 17, 2015
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Apr 1, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0801-2016, published Apr 13, 2016. 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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