Why it was recalled
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
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.
Lot numbers, UPCs & expiration codes
Lot #: 340353F, Exp 10/2018
Where it was sold
Nationwide and Australia
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0379-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 31, 2014
- FDA report date
- Jan 28, 2015
- Quantity
- 2,428 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-0379-2015, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70123
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: 340353F, Exp 10/2018
- Postal code
- 08807
- Report date
- Jan 28, 2015
- Product type
- Drugs
- Recall number
- D-0379-2015
- Classification
- Class II
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 2,428 vials
- Termination date
- Oct 4, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Australia
- Recall initiation date
- Dec 31, 2014
- Initial firm notification
- Press Release
- Center classification date
- Jan 22, 2015