FDA-Drug2013-04-03Class III
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
Pfizer Inc.
Hazard
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Sold states
Nationwide
Affected count
10920 kits
Manufactured in
235 East 42nd Street, New York, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-219-2013Don't want to check this manually?
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