Shire Voluntary Recalls One Batch of VPRIVBy
Shire Pharmaceuticals has initated a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV, a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy for pediatric and adult patients with Type 1 Gaucher disease. The recall was initiated 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. 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, reported te company
Shire reports that 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:, which involve visual inspection of the reconstituted VPRIV product prior to administration and andministering VPRIV through an in-line low protein-binding filter. The safety profile of VPRIV remains unchanged. VPRIV is supplied as a sterile, preservative-free, lyophilized powder in single-use vials, for intravenous use.
The 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 October 2015.
Shire has notified patients, hospitals, infusion clinics, and home health agencies via letter not to use product from the recalled lots. Shire said it 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. Unaffected lots of VPRIV can continue to be used according to the instructions for use.