FDA-Drug2017-11-08Class III
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.
Sanofi-Aventis U.S. LLC
Hazard
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Sold states
Nationwide in the USA
Affected count
422 vials
Manufactured in
55 Corporate Dr, N/A, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0056-2018Don't want to check this manually?
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