FDA recall D-0056-2018

Product

Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.

Reason for recall

Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-10-13

Report date

2017-11-08

Termination date

2020-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0056-2018