Sanofi-Aventis U.S. LLC recalls Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The…

Recall date

October 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0056-2018

FDA classification

Class III

Brand / firm

Sanofi-Aventis U.S. LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.