According to the US Food and Drug Administration (FDA), Teva Parenteral Medicines has initiated a voluntary nationwide recall of eight lots of Adrucil® (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL), owing to potential presence of particulate matter. The particulate matter has been identified as aggregates of silicone rubber pieces.
Please refer to the FDA website (given below in the reference information) for detailed information regarding affected product/s.
Adrucil®is used for pain management in different forms of cancer, namely, cancers of the colon, rectum, stomach, and pancreas.
According to the FDA, “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.”
Anyone who has the product is advised to discontinue use or distribution immediately and quarantine the affected lots immediately.
Teva Parenteral Medicines has not received any complaints thus far. Customers are requested to contact the Company at:
Teva Customer Service
Monday – Friday; 8:00 – 5:00 EST
Serious adverse events could also be reported to the FDA.
U.S. Food and Drug Administration. (n.d.). Retrieved May 5, 2015, from http://www.fda.gov/Safety/Recalls/ucm445584.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery