FDA recall D-0704-2017

Sanofi-Aventis U.S. LLC · Class III · drug

Product

Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01

Reason for recall

Labeling: Incorrect or Missing Package Insert

Distribution

Nattionwide

Key facts

Status
Terminated
Initiation date
2016-09-01
Report date
2017-05-17
Termination date
2018-02-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0704-2017