Shire Pharmaceuticals has a initiated 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.
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.
Importantly, there have been no reported adverse events or customer complaints associated with the use of these lots. To ensure that patients are not exposed to foreign particles during administration, Shire is reinforcing recommendations of the approved package insert in order to mitigate any risk: (1) visual inspection of the reconstituted VPRIV product should be done prior to administration and (2) VPRIV should be administered through an in-line low protein-binding filter. The safety profile of VPRIV remains unchanged.
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. This voluntary recall is limited to the following packaged lots: 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).
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Release Date: March 14, 2014
Source: Shire Pharmaceuticals