Valeant Recalls Virazole Due to Microbial Contamination
Valeant Pharmaceuticals is recalling Virazole (ribavirin) inhalation solution due to positive microbial contamination found during stability testing.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves microbial contamination of a sterile inhalation product, which poses a significant risk of serious injury or infection.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling 2,428 vials of Virazole (Ribavirin for Inhalation Solution, USP), sterile lyophilized for administration by aerosol inhalation only. The affected product is identified by Lot # 340353F with an expiration date of 10/2018. The product was distributed nationwide and in Australia.
The recall was initiated because Valeant's laboratory observed a positive microbial contamination of the specific lot during testing at the 12-month stability pull. This indicates a non-sterility issue with the product.
Healthcare providers and patients should stop using the affected lot immediately. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- 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.
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Inhalation Solution
- Affected units
- 2,428
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 340353F
- Exp 10/2018
Distribution
Distributed nationwide across the United States.
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