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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description 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
Recall Number D-219-2013
Classification Class III
Code Info Lots P00025A; P00027B
Product Distributed Qty 10920 kits
Reason For Recall Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.

Event Detail

Event Id 64690
Product Type Drugs
Status Ongoing
Recalling Firm Pfizer Inc.
City New York
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide