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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Manufacturer
- Genzyme Corporation / Genzyme Biosurgery
- Category
- Drug — Prescription Injection
- Hazard
- 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.
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