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.
Teva Parenteral Medicines today announced a voluntary recall of six lots of Adrucil® (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. The recalled lots are as follows:
Health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary.