Pfizer Recalls TORISEL Kits Due to Diluent Crystallization
Pfizer is recalling 16,000 TORISEL kits because impurities in the diluent may cause crystals to form after cold storage. The TORISEL drug vials are not affected.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Pfizer Inc. is recalling 16,000 kits of TORISEL (temsirolimus) injection, 25 mg/mL. The recall involves specific kit lots (AIEM/13, Exp 05/16) that contain diluent lots AHZW/11 and AHZW/12. These kits were distributed nationwide and in Puerto Rico.
The recall is due to a manufacturing issue where impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The source text explicitly states that the TORISEL vials themselves are not affected by this issue.
This is an FDA Class III recall, which indicates that the violation is not likely to cause adverse health consequences. Patients and healthcare providers should check their inventory for the affected lot numbers and contact Pfizer or their healthcare provider for further instructions.
The recalled product
- Product
- TORISEL (TEMSIROLIMUS)
- Brand
- TORISEL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 16,000
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)
- Kit Lot #: AIEM/13
- Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
Distribution
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