Shire Pharmaceuticals announced that it has initiated a voluntary nationwide recall of a single batch of VPRIV (velaglucerase alfa for injection), packaged into three lots. The company said the presence of visible particulate matter in the product caused the recall.
The company identified the particulates as stainless steel and barium sulfate, which was found in a small number of the vials in the affected package lots. An investigation by the company identified the root cause as being the third party supplier fill finish process.
Though safety risk to patients is considered very low, Shire said there is a possibility of rare but serious adverse events associated particularly with barium sulfate particulate. “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,” the company said in its press release.
Velaglucerase alfa for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long term enzyme replacement therapy (ERT) in children and adult patients with Type 1 Gaucher disease. VPRIV is manufactured and supplied as a sterile, preservative-free, lyophilized powder in single use vials for intravenous administration.
“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),” Shire informed in the release. There have been no reported adverse events or complaints associated with the use of the affected lots as of yet. Patients and healthcare professionals are advised to conduct a visual inspection of the product and to follow administration instructions to mitigate any risks.
The drug maker said it does not anticipate any disruption in its VPRIV supply as a result of the voluntary recall.