Genzyme Recalls Lumizyme Vials Due to Incorrect or Missing Lot and Expiration Dates
Genzyme Corporation is recalling 24 vials of Lumizyme (alglucosidase alpha) because the packaging may 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the hazard is limited to documentation/labeling issues.
Plain-English summary
Genzyme Corporation is recalling 24 vials of Lumizyme (alglucosidase alpha), 50 mg/vial, for intravenous infusion. The recall is limited to Lot # C5370C02 with an expiration date of 02/18. The product is distributed in Tennessee.
The recall was initiated due to a labeling defect where the lot number and/or expiration date on the packaging may be incorrect or missing. This is an FDA Class III recall, which indicates that the violation is not likely to cause adverse health consequences.
Healthcare providers and patients should check their inventory for this specific lot and expiration date. If the product is found, it should be quarantined and not administered until further notice. Patients should contact their healthcare provider for guidance on alternative treatment options if necessary.
The recalled product
- Product
- LUMIZYME (ALGLUCOSIDASE ALFA)
- Brand
- LUMIZYME
- Manufacturer
- Genzyme Corporation
- Category
- Drug — Prescription Biologic
- Hazard
- Affected units
- 24
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 # C5370C02
- Exp. 02/18
Distribution
Distributed in 1 state:
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