Drug recall D-219-2013

Class III Terminated reported Apr 3, 2013

Product

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

Reason for recall

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

Lots and codes

Lots P00025A; P00027B

Recall details

Recalling firm
Pfizer Inc., New York, NY
Quantity
10920 kits
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 26, 2012
Terminated
March 31, 2015

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