14th Mar 2014 16:31
LONDON (Alliance News) - Shire PLC said Friday that it has started a voluntary recall of one batch, packaged into three lots, of Gaucher disease treatment VPRIV due to the presence of visible particulate matter.
The particulate matter has been identified as stainless steel and barium sulphate, which was found in a small number of vials of three packaged lots of VRPIV.
Shire said that the risk to patients is very low, but if infused there is a possibility of rare but serious adverse events associated with particulate containing barium sulphate. Shire said it believes this risk was, and continues to be, mitigated by the required visual inspection of the reconstituted VRPIV product and by administration of VPRIC through an in-line low protein binding filter.
The product is being recalled and should not be used, Shire said. Shire has notified patients, hospitals, infusion clinics and home health agencies via letter not to use the product from the recalled lots.
Shire's investigation identified the root cause of the particulate matter to be a third party supplier fill finish process.
Shares in Shire were trading down 1.3% at 3,095.00 pence Friday afternoon.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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