Shire announced the a voluntary recall of one batch of Vpriv (velaglucerase alfa) due to the presence of visible stainless steel and barium sulfate in a number of vials. Shire identified that the root cause was from the third party supplier fill finish process.
The affected batch contains vials packaged into three lots. The recall is limited to the following lots: FEW13-001, FEW13-002, and FED13-006 with an expiration date of 10/15.
If the particulate matter is infused, there is a possibility of rare but serious adverse events related to barium sulfate. To mitigate any risk, the company is reinforcing the following recommendations: visual inspection of the reconstituted product prior to administration and administration through an in-line low protein-binding filter.
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.
Shire has notified patients, hospitals, infusion clinics, and home health agencies via letter not to use product from the recalled lots. Unaffected lots of Vpriv may continue to be used.
For more information call (888) 899-9293 or visit Shire.com.