FDAFDA · Food and drugs·Recall number D-0056-2018
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.
Published November 8, 2017 · Recall initiated: October 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot #: K5006Y02, Exp 31AUG18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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