Pfizer Recalls TORISEL Kits Due to Sterility and Endotoxin Concerns
Pfizer is recalling 10,920 TORISEL (temsirolimus) kits nationwide due to a lack of assurance of sterility and potential low-level endotoxins in the diluent vials.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Pfizer Inc. is recalling 10,920 kits of TORISEL (temsirolimus) injection, 25 mg/mL, concentrated, prescription only. The product is packaged in a carton containing one vial of TORISEL injection and one vial of diluent for TORISEL. The affected lots are P00025A and P00027B, and the product was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility and the potential that a low level of endotoxins may be present in the diluent vials. The FDA has classified this recall as Class III, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected TORISEL kits and contact Pfizer or their healthcare provider for further instructions or replacement products.
The recalled product
- Product
- TORISEL (TEMSIROLIMUS)
- Brand
- TORISEL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 10,920
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots P00025A
- P00027B
Distribution
Distributed nationwide across the United States.
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