Recalls / Class III
Class IIID-0704-2017
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
- Brand name
- Mozobil
- Generic name
- Plerixafor
- Active ingredient
- Plerixafor
- Route
- Subcutaneous
- NDC
- 0024-5862
- FDA application
- NDA022311
- Affected lot / code info
- Lot #: 5RZ001C, 5RZ001D; Exp. 04/18
Why it was recalled
Labeling: Incorrect or Missing Package Insert
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, N/A, Bridgewater, New Jersey 08807-1265
Distribution
- Quantity
- 2133 vials
- Distribution pattern
- Nattionwide
Timeline
- Recall initiated
- 2016-09-01
- FDA classified
- 2017-05-11
- Posted by FDA
- 2017-05-17
- Terminated
- 2018-02-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0704-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.