Teva recalls lots of Adrucil in USA

28 July 2015

Teva Parenteral Medicines, a unit of Israeli generics giant Teva Pharmaceuticals Industries (NYSE: TEVA), has voluntarily recalled six lots of Adrucil (fluorouracil injection, USP) 5g/100 mL (50mg/mL), the US Food and Drug Administration announced yesterday.

The recall is due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals, the FDA has reported.

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. To date, Teva has not received any reports of adverse events related to this recall. 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.

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