Recalls / Class III
Class IIID-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.
- Brand name
- Torisel
- Generic name
- Temsirolimus
- NDC
- 0008-1179
- FDA application
- NDA022088
- Affected lot / code info
- Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
Why it was recalled
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.
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, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 16,000 kits
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-10-10
- FDA classified
- 2014-11-04
- Posted by FDA
- 2014-11-12
- Terminated
- 2017-04-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0235-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.