FDA Drug recall 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…
- FDA Drug
- Class III
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class III recall of TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial… by Pfizer, citing lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-219-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-11-26 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pfizer |
| Distribution | US |
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
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Identifiers
| ndc | 0008-1179-01 |
|---|---|
| ndc | 0008-1279-01 |
| ndc | 0008-1125-01 |
| code_info | Lots P00025A; P00027B |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-219-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.