IGMPI India

Shire Pharmaceuticals has announced the nationwide voluntary recall of one batch, packed into three lots of VPRIV in United States. The recall was initiated due to presence of visible particulate matter, identified as stainless steel and barium sulfate. The visible particulate matter was found in a small number of vials in the three packaged lots of VPRIV.

VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease. VPRIV is supplied as a sterile, preservative-free, lyophilized powder in single-use vials, for intravenous use.

The company has identified the root cause of the problem as the finishing process at the third party supplier. Shire pharmaceutical believes that there is very low safety risk to the patients but there is a possibility of rare but serious adverse events associated with particulate containing barium sulfate. The recall is limited to the following packaged lots: FEW13-001, FEW13-002, and FED13-006. The manufacturing date of vials is supposed to be in March as VPRIV has an 18 months shelves life and the expiration date on the vials was October 2015.

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.