Virazole
FDA Recall NDC 0187-0007
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Virazole (NDC 0187-0007). A significant event, classified as Class II, was initiated on Dec 31, 2014 by Bausch Health Us, Llc. The reported reason for this action was: "Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Dec 31, 2014
Jan 28, 2015
2,428 vials
Recall Profile & Regulatory Data
Event ID
70123
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Valeant Pharmaceuticals North America LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Australia
Termination Date
Oct 04, 2017
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.
Batch or Lot Expiration Information
Lot# : 340353F, Exp 10/2018
Affected Packages Involved in this Recall
0187-0007-14Product
0187-0007-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
