Valeant recalls drug used on hospitalised infants
pharmafile | January 6, 2015 | News story | Manufacturing and Production, Sales and Marketing | Actavis, Allergan, FDA, Valeant, manufacturing, recall, ribavirin, virazole
North American drug firm Valeant Pharmaceuticals has issued a voluntary nationwide recall of Virazole due to microbial contamination.
Virazole (ribavirin powder for solution) is indicated for the treatment of hospitalised infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus.
The firm says inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection. The risk is higher in patients who are immunocompromised (because of underlying disease), and are more susceptible.
Valeant says in a statement that it is “notifying its distributors and customers by mail and is arranging for return of all recalled product of this lot. This recall only affects this lot of Virazole; all other lots are not affected and are not involved in this recall”.
An FDA notice says the firm’s New Jersey-based operation is voluntarily recalling one lot of Virazole and that the recall was issued on 30 December. The powder is reconstituted in 300 millilitres of sterile water then put into an inhaler for use.
This is not the only recall Valeant has faced recently, as only in October the company clawed back around 200,000 bottles of blood pressure medication vaseretic due to labelling issues. It has also recalled more than 35,000 tubes of hydrocortisone butyrate cream for not meeting potency standards.
But this latest news only serves to damage Valeant’s reputation further, and arrives also in the wake of its several failed bids and hostile attempts to acquire Botox manufacturer Allergan – only for it to be snapped up by Actavis for $66 billion.
Valeant’s last $54 billion offer was rejected just prior to that, seeing the company miss out on a deal described as ‘financially compelling’. The transaction is expected to close during the second quarter of this year and creates, Actavis says, “one of the world’s top 10 pharmaceutical companies”.
Valeant had even been trying to court healthcare professionals in Allergan’s major franchises within cosmetic care leading up to the bids. The firm said it had met with 45 influential cosmetic surgeons and dermatologists who use Allergan’s Botox to try and win them over.
The company reportedly paid for the clinicians’ flights, hotels and meals and agreed to pay consulting fees of up to $30,000 according to the Wall Street Journal.
Brett Wells
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