CLASS III Drug recall · Reported 17 May 2017 · FDA Enforcement Report
Mozobil (plerixafor injection) 24mg/ (20mg/mL), For Single Use Only recalled
Sanofi-Aventis U.S is recalling Mozobil (plerixafor injection) 24mg/ (20mg/mL), For Single Use Only. The recall was initiated on 1 Sep 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-0704-2017
- FDA event ID
- 76896
- Recalling firm
- Sanofi-Aventis U.S, Bridgewater, NJ
- Brand
- Mozobil
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Sep 2016
- FDA classified
- 11 May 2017
- Reported
- 17 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Sep 2016 | Recall initiated by company | |
| 11 May 2017 | Classified by FDA | +252 days |
| 17 May 2017 | 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 Package Insert
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nattionwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Package Insert
Which lots are affected?
Lot #: 5RZ001C, 5RZ001D; Exp. 04/18
Where was it sold?
Nattionwide
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.
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Other Plerixafor recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Mozobil (plerixafor injection) 24 mg/ (20 mg/mL) per vial recalledMozobil | Genzyme Corporation / Genzyme Biosurgery | Other | Nationwide |