FDA Recall D-1507-2020
Sanofi-Aventis U.S. LLC · Bridgewater, NJ
Class II Ongoing 2103 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Recall record
- Recall number
D-1507-2020- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2020-08-10
- Classified by FDA Center
- 2020-08-17
- FDA published
- 2020-08-26
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Firm location
- Bridgewater, NJ
Drug identification
- Brand name(s)
- ELITEK
- Generic name(s)
- RASBURICASE
- Manufacturer(s)
- Sanofi-Aventis U.S. LLC
- NDC(s)
0024-5150, 0024-5151
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.