Elitek Kit
FDA Recall NDC 0024-5151
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Elitek (NDC 0024-5151). A significant event, classified as Class II, was initiated on Aug 10, 2020 by Sanofi-aventis U.s. Llc. The reported reason for this action was: "Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Aug 10, 2020
Aug 26, 2020
7451 vials
Recall Profile & Regulatory Data
Event ID
86219
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Sanofi-Aventis U.S. LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Batch or Lot Expiration Information
Lot# : A9306, Exp 2/28/2022
Affected Packages Involved in this Recall
0024-5150-10Product
0024-5154-11Product
0024-5152-11Product
0024-5151-75Product
0024-5155-74Product
0024-5153-74Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
