FDAFDA · Food and drugs·Recall number D-219-2013
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
Published April 3, 2013 · Recall initiated: November 26, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TORISEL
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide
- Lot
- Lots P00025A; P00027B
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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