Drug recall D-0075-2018

Class III Terminated reported Nov 22, 2017

Product

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.

Lots and codes

Lot #: K5006Y01; Exp. 08/31/18 Lot #: K5006Y03; Exp. 08/31/18 Lot #: K6001Y01; Exp. 03/31/19

Recall details

Recalling firm
Genzyme Corporation, Northborough, MA
Quantity
9,343 single dose vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
October 12, 2017
Terminated
September 10, 2020