Home / Recalls / Sanofi-Aventis U.S. LLC / D-1507-2020

D-1507-2020 Class II Ongoing

Recalled by Sanofi-Aventis U.S. LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
August 26, 2020
Initiation Date
August 10, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7451 vials

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.

Distribution Pattern

Nationwide in the US

Code Information

Lot #: A9306, Exp 2/28/2022

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  • D-0539-2020 Class II — Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company (October 22, 2019)
  • D-0534-2020 Class II — Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, (October 22, 2019)