FDA recall D-1518-2016

Genzyme Corporation / Genzyme Biosurgery · Class III · drug

Product

Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp. Date

Distribution

nationwide

Key facts

Status
Terminated
Initiation date
2016-08-04
Report date
2016-09-28
Termination date
2018-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ridgefield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1518-2016