October 2014 FDA Recall Torisel by Pfizer Inc.
D-0235-2015 - Crystallization

This Class III drug recall was voluntarily initiated by Pfizer Inc. on October 10, 2014 for the product Torisel. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0235-2015

Reason for Recall
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.
Initiated
10-10-2014
Reported
11-12-2014
Quantity
16,000 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69479
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-14-2017
Product Description About Product Description
Full technical description of the product.
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

0008-1179-01 Torisel