FDA-Drug2017-11-22Class III

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.

Genzyme Corporation
Hazard

Labeling: Incorrect or Missing Package Insert.

Sold states
Nationwide
Affected count
9,343 single dose vials
Manufactured in
11 Forbes Rd, N/A, Northborough, MA, United States
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, NDC 0024-5860-01.

Official notice

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

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