US Drug Recall Register
Class III · Low risk Terminated Initiated Oct 10, 2014 (12 years ago)

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of…

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

Why it was recalled

Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.

What was recalled

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent  MADE IN ITALY; 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-0235-2015

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.

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