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Recall Observatory FDA recall evidence

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

D-1518-2016

August 04, 2016

Class III

Product summary

Firm
Genzyme Corporation / Genzyme Biosurgery
Event
Event 74968
Status
Terminated
Classification
Class III
Quantity
9,530 vials
Official record key
drug-enforcement:D-1518-2016

Official wording

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

Code information: Lot # 5RZ002; Exp. 04/18

Distribution pattern: nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing