Teva announced a voluntary recall of 6 lots of Adrucil (fluorouracil injection) 5g/100mL (50mg/mL) due to potential particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Adrucil Injection is an antimetabolite indicated for use in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas. Giving an intravenous product with particulate matter can lead to inflammation, allergic reactions, or blockage of blood vessels, which may be life-threatening. The affected products are individual 5mg/100mL vials as well as the 5-count pharmacy bulk packages. The full list can be found here.
Teva has notified its direct customers and is arranging for affected products to be returned. No adverse events related to the recall have been reported to date.
For more information call (888) 838-2872 or visit TevaPharm.com.