06 May 2015 | Regulatory | By BioSpectrum Bureau
Teva suspects foriegn material in Adrucil injection
Teva has suspected foriegn material in Adrucil injection
Singapore: Teva Parenteral Medicines has issued a voluntary recall of eight lots of Adrucil (fluorouracil injection) due to suspected presence of particulate matter identified as 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.