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FDA Medwatch Alert: VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter
Posted 20 Mar 2014 by Drugs.com
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 ... Read more