Torisel Kit
FDA Recall NDC 0008-1179
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Torisel (NDC 0008-1179). A significant event, classified as Class III, was initiated on Oct 10, 2014 by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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.
Oct 10, 2014
Nov 12, 2014
16,000 kits
Recall Profile & Regulatory Data
Event ID
69479
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Apr 14, 2017
Product Description
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.
Batch or Lot Expiration Information
Lot# Kit
Lot# : AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
Affected Packages Involved in this Recall
0008-1179-01Product
0008-1279-01Product
0008-1125-01Product
November 2012 Class III Recall: Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Recall Number
Class III Terminated
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Nov 26, 2012
Apr 03, 2013
10920 kits
Recall Profile & Regulatory Data
Event ID
64690
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 31, 2015
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
Batch or Lot Expiration Information
Lot# Lots P00025A; P00027B
Affected Packages Involved in this Recall
0008-1179-01Product
0008-1279-01Product
0008-1125-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
