Class III
Terminated
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.
- Company
- Sanofi-Aventis U.S. Llc
- Recall Initiated
- October 13, 2017
- Posted
- November 8, 2017
- Recall Number
- D-0056-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 422 vials
- Firm Location
- Bridgewater, NJ, United States
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
Nationwide in the USA
Lot / Code Info
Lot #: K5006Y02, Exp 31AUG18
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