Teva Recalls Adrucil Injections Distributed to Pharmacies

Teva is voluntarily recalling select lots of intravenous fluorouracil (Adrucil).

Teva’s parenteral medicines branch is voluntarily recalling select lots of intravenous fluorouracil (Adrucil) due to particulate matter discovered in some vials distributed in the United States.

The company identified the particulate matter in 8 lots of Adrucil 50 mg/mL as an aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. If a tainted product is administered, it could result in inflammation, allergic reactions, or blood vessel blockage, leading to organ tissue death that could be life threatening, Teva noted.

Adrucil is used to manage carcinoma of the colon, rectum, breast, stomach, and pancreas. The drug has been distributed to wholesalers, retailers, and pharmacies.

Teva notified its direct customers of the recall via mail and also issued an Urgent Drug Recall letter. Those who have received potentially tainted products are advised to stop using them immediately. Patients and health care professionals can report issues related to the recalled drugs to the FDA’s MedWatch Adverse Event Reporting Program online or via regular mail.