Drug 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.
D-0235-2015
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 69479
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16,000 kits
- Official record key
drug-enforcement:D-0235-2015
Official wording
Reason: 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.
Code information: Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
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.