Valeant says inhaled drug used on infants may be contaminated

Valeant Pharmaceuticals ($VRX) has started the new year with a product recall. This time the drugmaker is recalling an inhaled med that can be used to treat hospitalized infants, one which it says is suspected of having microbial contamination.

According to an FDA MedWatch notice, the drugmaker's Bridgewater, NJ-based North American operation is voluntarily recalling one lot of Virazole (ribavirin powder for solution). The recall was issued Dec. 30. The powder is reconstituted in 300 milliliters of sterile water then put into an inhaler for use.

Inhaling a microbial contaminated medicine could cause infections and is particularly dangerous for "immunocompromised" patients, Valeant points out. The nucleoside inhibitor is often used to treat patients with hepatitis C. Valeant's ribavirin is approved for use in hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV). So far, the company said there have been no reports of injuries or adverse events.

Valeant has had several recalls in recent months. In October, the company recalled nearly 206,000 bottles of blood pressure medication vaseretic because of labeling problems. It also recalled more than 35,000 tubes of hydrocortisone butyrate cream for not meeting potency standards at the 18-month mark. Earlier last year, Valeant's Bausch + Lomb unit recalled 850,000 lots of Muro 128 ointment, as well as 35,000 tubes of an unbranded sodium chloride product sold by Major Pharmaceuticals after users complained of a "gritty, sandlike feeling" in the eye. In those cases, the drugmaker believed the products froze when they were being shipped.

- read the FDA MedWatch announcement
- see Valeant's release

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

The FDA hit New Jersey-based CMO Tris Pharma with a warning letter, citing significant violations.