Recalls / Class III
Class IIID-219-2013
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
- Brand name
- Torisel
- Generic name
- Temsirolimus
- NDC
- 0008-1179
- FDA application
- NDA022088
- Affected lot / code info
- Lots P00025A; P00027B
Why it was recalled
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 10920 kits
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-11-26
- FDA classified
- 2013-03-26
- Posted by FDA
- 2013-04-03
- Terminated
- 2015-03-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-219-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.