AUDIENCE: Risk Manager, Pharmacy
ISSUE: Shire Pharmaceuticals announced a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV 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.
If infused, there is a possibility of rare but serious adverse events associated with particulate containing barium sulfate.
The following packaged lots were recalled: FEW13-001, FEW13-002, and FED13-006. These lots were distributed nationwide to hospitals, infusion clinics, patients, and home health agencies in the United States and all have the same NDC code (54092-701-04) and same expiration date of 10/15 (Oct 2015).
BACKGROUND: 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.
RECOMMENDATION: Customers should locate and remove all affected product from their facility and/or residence. Affected product should be returned by contacting Shire at 1-888-899-9293 (Monday through Friday between the hours of 8:00am and 5:00pm Eastern Time). Shire has significant quantities of VPRIV to replace any affected product. Shire does not anticipate any disruption in supply as a result of this voluntary recall.