December 2015 FDA Recall Drug by Virtus Pharmaceuticals, Llc
D-0801-2016 - Defective Delivery System
This Class III drug recall was voluntarily initiated by Virtus Pharmaceuticals, Llc on December 17, 2015 for the product Drug. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0801-2016
Defective Delivery System: Product may contain leaking capsules.
12-17-2015
04-13-2016
688 bottles ( 20,640 softgel capsules)
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
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.
General area of initial distribution.
Nationwide
08-16-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 21506132; Exp. 05/17
