Elitek recall
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Why was Elitek recalled?
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: A9306, Exp 2/28/2022
- Product
- Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Quantity
- 7451 vials
- Distribution
- Nationwide in the US
- Recall date
- August 26, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)