Skip to content
Recall Observatory FDA recall evidence

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

D-0704-2017

September 01, 2016

Class III

Product summary

Firm
Sanofi-Aventis U.S. LLC
Event
Event 76896
Status
Terminated
Classification
Class III
Quantity
2133 vials
Official record key
drug-enforcement:D-0704-2017

Official wording

Reason: Labeling: Incorrect or Missing Package Insert

Code information: Lot #: 5RZ001C, 5RZ001D; Exp. 04/18

Distribution pattern: Nattionwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing