Sanofi Recalls Elitek (Rasburicase) Vials Due to Stability Testing Failures
Sanofi-Aventis is recalling 7,451 vials of Elitek (rasburicase) because routine stability testing showed enzyme activity levels were out of specification.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving potential quality issues without immediate harm.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling 7,451 vials of Elitek (rasburicase) for injection, 7.5 mg. The recall involves Lot A9306, which has an expiration date of 2/28/2022. The product is distributed nationwide in the US.
The recall was initiated because routine stability testing revealed out-of-specification results for enzyme activity levels. This indicates that the product may not meet its required stability specifications.
Healthcare providers and patients should stop using the affected vials and contact Sanofi-Aventis for further instructions or to arrange for return of the product.
The recalled product
- Product
- ELITEK (RASBURICASE)
- Brand
- ELITEK
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Category
- Drug — Prescription Injection
- Affected units
- 7,451
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)
- Lot #: A9306
- Exp 2/28/2022
Distribution
Distributed nationwide across the United States.
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