December 2014 FDA Recall Virazole by Valeant Pharmaceuticals North America Llc
D-0379-2015 - Non-Sterility

This Class II drug recall was voluntarily initiated by Valeant Pharmaceuticals North America Llc on December 31, 2014 for the product Virazole. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0379-2015

Reason for Recall
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Initiated
12-31-2014
Reported
01-28-2015
Quantity
2,428 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70123
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Valeant Pharmaceuticals North America 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Australia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-04-2017
Product Description About Product Description
Full technical description of the product.
Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14.

Batch or Lot Expiration Information

Lot# : 340353F, Exp 10/2018

Affected Packages Involved in this Recall

0187-0007-14 Virazole
0187-0007-01 Virazole