TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton cont...
FDA Recall #D-219-2013 — Class III — November 26, 2012
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
Reason for Recall
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
10920 kits
Distribution
Nationwide
Code Information
Lots P00025A; P00027B
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated