January 2016 FDA Recall Drug by Virtus Pharmaceuticals, Llc (D-0775-2016 - Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).)

This Class III drug recall was voluntarily initiated by Virtus Pharmaceuticals, Llc on January 15, 2016 for the product Drug. The FDA reported the reason for recall as tablets/capsules imprinted with wrong id; product debossed with an incorrect punch. bottles could contain tablets debossed with v259 (debossing for pretab) instead of the correct punch, v264 (debossing for virt-nate).. The product was distributed in MI and the recall is currently terminated.

Recall Number: D-0775-2016

Reason for Recall
Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
Initiated
01-15-2016
Reported
03-23-2016
Quantity
1,139 bottles total

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73480
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, Llc
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MI
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-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL

Batch or Lot Expiration Information

Lot# Lot code M143810A, exp 7/2017, NDC 69543-264-10, UPC 369543264105, and Lot code M143810, exp 7/2017, NDC 76439-264-10, UPC 376439264109