The Recall Desk
LowFDA (Drugs)·D-1518-2016·Announced 2016-09-28

Genzyme Recalls Mozobil Vials Due to Incorrect or Missing Lot and Expiration Dates

Genzyme is recalling 9,530 vials of Mozobil (plerixafor) because some have incorrect or missing lot and expiration dates.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling defect (missing/incorrect dates) rather than a direct safety hazard like contamination or dosage error.

Plain-English summary

Genzyme Corporation is voluntarily recalling 9,530 vials of Mozobil (plerixafor) 24 mg/1.2 mL (20 mg/mL) for subcutaneous injection. The recall is due to a labeling defect where some vials have incorrect or missing lot and expiration dates.

The affected product is identified by Lot # 5RZ002 with an expiration date of 04/18. The vials were distributed nationwide. Mozobil is a prescription drug used to increase hematopoietic stem cell mobilization.

Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or Genzyme for further instructions. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
MOZOBIL (PLERIXAFOR)
Brand
MOZOBIL
Affected units
9,530

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 5RZ002
  • Exp. 04/18

Distribution

Distributed nationwide across the United States.

Same brand · MOZOBIL

Same manufacturer · Genzyme Corporation / Genzyme Biosurgery

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