CLASS III Drug recall · Reported 28 Sep 2016 · FDA Enforcement Report
Mozobil (plerixafor injection) 24 mg/ (20 mg/mL) per vial recalled
Genzyme Corporation / Genzyme Biosurgery is recalling Mozobil (plerixafor injection) 24 mg/ (20 mg/mL) per vial, distributed nationwide in the US. The recall was initiated on 4 Aug 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1518-2016
- FDA event ID
- 74968
- Recalling firm
- Genzyme Corporation / Genzyme Biosurgery, Ridgefield, NJ
- Brand
- Mozobil
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Aug 2016
- FDA classified
- 22 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Aug 2016 | Recall initiated by company | |
| 22 Sep 2016 | Classified by FDA | +49 days |
| 28 Sep 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp. Date
Product as listed by the FDA
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
Where it was distributed
nationwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp. Date
Which lots are affected?
Lot # 5RZ002; Exp. 04/18
Where was it sold?
nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Genzyme Corporation / Genzyme Biosurgery
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hectorol (doxercalciferol injection) 2 mcg recalled | Genzyme Corporation / Genzyme Biosurgery | Other | MI, NJ, PA |
Other Plerixafor recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Mozobil (plerixafor injection) 24mg/ (20mg/mL), For Single Use Only recalledMozobil | Sanofi-Aventis U.S | Packaging Defects | NJ |