Shire recalls batch of VPRIV in USA

Shire Pharmaceuticals announced the initiation of a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV (velaglucerase alfa for injection) due to the presence of visible particulate matter, identified as stainless steel and barium sulfate. The particulate matter was found in a small number of vials in the three packaged lots of VPRIV. A Shire investigation identified the particulate matter root cause as the third party supplier fill finish process.

Shire believes the safety risk to patients is very low. If infused, there is a possibility of rare but serious adverse events associated with particulate containing barium sulfate. Shire believes this health risk was and continues to be mitigated by the package insert�s required visual inspection of the reconstituted VPRIV product and by administration of VPRIV through an in-line low protein-binding filter. The product is being recalled and should not be used.