Home / Recalls / Sanofi-Aventis U.S. LLC / D-0056-2018

D-0056-2018 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
November 8, 2017
Initiation Date
October 13, 2017
Termination Date
May 13, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
422 vials

Product Description

Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.

Reason for Recall

Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: K5006Y02, Exp 31AUG18

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