Teva Parenteral Medicines of North Wales, PA, recently recalled six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as an aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.
Adrucil Injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach, and pancreas and is packaged in pharmacy bulk packages. The pharmacy bulk package has five 5 g/100ml vials per shelf pack. Individual Adrucil 5 g/100 ml vials have the NDC code 0703-3019-11 and the pharmacy shelf pack has the NDC code 0703-3019-12. The Adrucil 5 g/100 ml vial can be further identified by the statement on the label in red that states “PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION.”
Adrucil 5 g/100 ml vials were distributed in the United States. Teva has distributed this product nationwide through wholesalers, retailers, and pharmacies.
See the Recall
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