PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: November 22, 2017 Initiated: October 12, 2017 #D-0075-2018

Product Description

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.

Reason for Recall

Labeling: Incorrect or Missing Package Insert.

Details

Recalling Firm
Genzyme Corporation
Units Affected
9,343 single dose vials
Distribution
Nationwide
Location
Northborough, MA

Frequently Asked Questions

What product 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.. Recalled by Genzyme Corporation. Units affected: 9,343 single dose vials.
Why was this product recalled?
Labeling: Incorrect or Missing Package Insert.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 22, 2017. Severity: Low. Recall number: D-0075-2018.