Sanofi Recalls Mozobil Vials Due to Incorrect or Missing Package Insert
Sanofi-Aventis is recalling 2,133 vials of Mozobil (plerixafor) nationwide because the package insert is incorrect or missing.
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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is limited to packaging documentation.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling 2,133 vials of Mozobil (plerixafor) injection, 24mg/1.2mL, distributed nationwide. The recall was initiated because the product has an incorrect or missing package insert.
The affected product is identified by Lot numbers 5RZ001C and 5RZ001D, with an expiration date of 04/18. The vials are intended for subcutaneous use and are manufactured by Genzyme Corporation.
Healthcare providers and patients should stop using the affected vials and contact Sanofi-Aventis for further instructions or replacement.
The recalled product
- Product
- MOZOBIL (PLERIXAFOR)
- Brand
- MOZOBIL
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 2,133
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 (3)
- Lot #: 5RZ001C
- 5RZ001D
- Exp. 04/18
Distribution
Distribution scope not specified by the agency.
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