Class III · Low risk
TORISEL Kit
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.
National Drug Code
Is NDC 0008-1179-01 recalled?
Torisel · 1 KIT in 1 CARTON (0008-1179-01) * 25 mL in 1 VIAL, SINGLE-USE (0008-1279-01) * 1.8 mL in 1 VIAL, SINGLE-USE (0008-1125-01)
Yes — this exact package was recalled
2 FDA recalls name the code 0008-1179-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- temsirolimus
- Form
- Kit
- Labeler
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Type
- Human Prescription Drug
- Product code
- 0008-1179
Recalls naming this package
Class III · Low risk
TORISEL Kit
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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