Genzyme Corporation / Genzyme Biosurgery Mozobil Recall

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot # 5RZ002; Exp. 04/18

Where it was sold

nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1518-2016
Classification: Class III
Status: Terminated
Recall initiated: Aug 4, 2016
FDA report date: Sep 28, 2016
Quantity: 9,530 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Genzyme Corporation / Genzyme Biosurgery

Original FDA data

Every field from FDA enforcement report D-1518-2016, exactly as published.

Show all FDA fields

City: Ridgefield
State: NJ
Status: Terminated
Country: United States
Event ID: 74968
Address: 1125 Pleasantview Ter
Code information: Lot # 5RZ002; Exp. 04/18
Postal code: 07657-2310
Report date: Sep 28, 2016
Product type: Drugs
Recall number: D-1518-2016
Classification: Class III
Recalling firm: Genzyme Corporation / Genzyme Biosurgery
Product quantity: 9,530 vials
Termination date: Apr 19, 2018
Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp. Date
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: nationwide
Recall initiation date: Aug 4, 2016
Initial firm notification: Letter
Center classification date: Sep 22, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1518-2016, published Sep 28, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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