TORISEL Kit — Class III drug recall D-219-2013
Terminated recall by Pfizer Inc., reported 2013-04-03, distributed nationwide. Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
| Recall number | D-219-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2012-11-26 |
| Classified | 2013-03-26 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2015-03-31 |
| Distributed | Nationwide (US) |
| Quantity | 10,920 kits |
| Reason classes | sterility |
| NDC | 00008-1125-01, 00008-1179, 00008-1179-01, 00008-1279-01 |
| Lot numbers | P00025A, P00027B |
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
Reason for recall
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-219-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.