Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Reported: August 26, 2020 Initiated: August 10, 2020 #D-1507-2020
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
Reason for Recall
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Details
- Recalling Firm
- Sanofi-Aventis U.S. LLC
- Units Affected
- 7451 vials
- Distribution
- Nationwide in the US
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75. Recalled by Sanofi-Aventis U.S. LLC. Units affected: 7451 vials.
Why was this product recalled? ▼
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 26, 2020. Severity: Moderate. Recall number: D-1507-2020.
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