US Drug Recall Register
Class III · Low risk Terminated Initiated Nov 26, 2012 (14 years ago)

TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.

What was recalled

TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01

Recalling firm
Pfizer Inc.
NDC code
0008-1179-01
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-219-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Sirolimus recalls

See all