Drug 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
D-219-2013
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 64690
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10920 kits
- Official record key
drug-enforcement:D-219-2013
Official wording
Reason: Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Code information: Lots P00025A; P00027B
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility