November 2012 FDA Recall Torisel by Pfizer Inc.
D-219-2013 - Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.

This Class III drug recall was voluntarily initiated by Pfizer Inc. on November 26, 2012 for the product Torisel. The FDA reported the reason for recall as lack of assurance of sterility; potential that a low level of endotoxins may be present in the diluent vials.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-219-2013

Reason for Recall
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Initiated
11-26-2012
Reported
04-03-2013
Quantity
10920 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64690
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-31-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lots P00025A; P00027B

Affected Packages Involved in this Recall

0008-1179-01 Torisel