Drug recall D-0235-2015
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.
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.
Lots and codes
Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Quantity
- 16,000 kits
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 10, 2014
- Terminated
- April 14, 2017
Related products
- Torisel – drug information
- NDC 0008-1179 Torisel · · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.