Genzyme Corporation recalls Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg…

Recall date

October 12, 2017

Source

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

Recall number

D-0075-2018

FDA classification

Class III

Brand / firm

Genzyme Corporation

Sold / distributed

Nationwide

Why it was recalled

Labeling: Incorrect or Missing Package Insert.

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

What was recalled

Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.