FDA recall D-0075-2018

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-10-12

Report date

2017-11-22

Termination date

2020-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2018