Class III · Low risk Ongoing
Sirolimus Tablets 1mg Tablets 100-count bottle
Reason Failed Impurities/Degradation Specifications
TORISEL Kit
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
What was recalled
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
- Recalling firm
- Pfizer Inc.
- NDC code
- 0008-1179-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-219-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Sirolimus recalls
See all
Class III · Low risk Terminated
Fyarro
Reason Failed Stability Specifications
Class III · Low risk Terminated
Sirolimus Oral Solution
Reason Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class III · Low risk Terminated
Sirolimus Tablets 1 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Sirolimus Tablets
Reason Failed impurities/degradation: out of specification result for impurity secorapamycin.
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