drugs Class III Updated 2014-11-12

Pfizer Inc. recalls TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TO

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
View official government recall

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