Home / Recalls / Valeant Pharmaceuticals North America LLC / D-0379-2015

D-0379-2015 Class II Terminated

Recalled by Valeant Pharmaceuticals North America LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
January 28, 2015
Initiation Date
December 31, 2014
Termination Date
October 4, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,428 vials

Product Description

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.

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.

Distribution Pattern

Nationwide and Australia

Code Information

Lot #: 340353F, Exp 10/2018

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