Teva Recalls Injectable Due to Particulates

May 11, 2015

Particulates have forced yet another drugmaker — this time Teva — to recall an injectable. The drugmaker voluntarily recalled eight lots of its anticancer therapy Adrucil after a combination of silicone rubber from a filling diaphragm and fluorouracil crystals was found in vials.

The recall follows similar recalls involving particulates by Hospira, Sun Pharma, Baxter and Mylan.

Teva says it has not received any reports of adverse events related to the recall. Adrucil (fluorouracil injection) 5g/100ml is packaged in pharmacy bulk packages containing five 5g/100ml vials per shelf pack. 

Teva spokeswoman Denise Bradley said the particulates were not caused by a manufacturing error and the recall will not cause a shortage of the product.

To read the recall notice, go to www.fdanews.com/05-06-15-TevaRecall.pdf. — Kellen Owings