NDC 0008-1179
Torisel 25 mg per 1 mL kit
On the label: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pfizer Ireland Pharmaceuticals Unlimited Company | Ringaskiddy, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyOct 25, 2024 · 6 inspections |
| Pfizer Ireland Pharmaceuticals Unlimited Company | Newbridge, Ireland | Tests it | Problems found, fixed voluntarilySep 23, 2022 · 8 inspections |
| Pfizer Manufacturing Belgium NV | Puurs-Sint-Amands, Belgium | Tests it | Problems found, fixed voluntarilyJun 22, 2022 · 5 inspections |
| Wyeth Lederle SRL | Catania, Italy | Tests it and labels it | Problems found, fixed voluntarilyNov 15, 2024 · 6 inspections, 2 with FDA action |
Recalls
- Oct 10, 2014 · Class III · Pfizer Inc.
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
Lots: Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12 - Nov 26, 2012 · Class III · Pfizer Inc.
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Lots: Lots P00025A; P00027B
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Temsirolimus: every company that makes it
- Form
- kit
- Strength
- 25 mg per 1 mL
- Approval
- NDA NDA022088
- On the market since
- Jul 1, 2007
- Package NDCs
0008-1125-010008-1179-010008-1279-01- Official label
- DailyMed (National Library of Medicine), updated Dec 26, 2025
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