Recalls / Class III
Class IIID-1518-2016
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
- Brand name
- Mozobil
- Generic name
- Plerixafor
- Active ingredient
- Plerixafor
- Route
- Subcutaneous
- NDC
- 0024-5862
- FDA application
- NDA022311
- Affected lot / code info
- Lot # 5RZ002; Exp. 04/18
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp. Date
Recalling firm
- Firm
- Genzyme Corporation / Genzyme Biosurgery
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1125 Pleasantview Ter, Ridgefield, New Jersey 07657-2310
Distribution
- Quantity
- 9,530 vials
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2016-08-04
- FDA classified
- 2016-09-22
- Posted by FDA
- 2016-09-28
- Terminated
- 2018-04-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1518-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.