Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # C5370C02; Exp. 02/18
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Genzyme Corporation
- Reason for Recall:
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1
Product Codes/Lot Numbers:
Lot # C5370C02; Exp. 02/18
Distribution:
Distributed in: TN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0799-2016
Related Recalls
Labeling: Incorrect or Missing Package Insert.
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Presence of Particulate Matter: Glass particles found in the product after reconstitution.