FDA Drug Class III — Least Serious

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.

Hazard

Labeling: Incorrect or Missing Package Insert.

Products

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
Brand
Genzyme Corporation
UPC
Lot #: K5006Y01; Exp. 08/31/18 Lot #: K5006Y03; Exp. 08/31/18 Lot #: K6001Y01; Exp. 03/31/19

Units Affected

9,343 single dose vials