Why it was recalled
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
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
Lot numbers, UPCs & expiration codes
Lot #: A9306, Exp 2/28/2022
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1507-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 10, 2020
- FDA report date
- Aug 26, 2020
- Quantity
- 7451 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanofi-Aventis U.S. LLC
Original FDA data
Every field from FDA enforcement report D-1507-2020, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 86219
- Address
- 55 Corporate Dr
- Code information
- Lot #: A9306, Exp 2/28/2022
- Postal code
- 08807-1265
- Report date
- Aug 26, 2020
- Product type
- Drugs
- Recall number
- D-1507-2020
- Classification
- Class II
- Recalling firm
- Sanofi-Aventis U.S. LLC
- Product quantity
- 7451 vials
- Reason for recall
- Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Aug 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2020