Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1

FDA recall notice · announced April 6, 2016 · Genzyme

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Notes

Distribution: TN
Lot/code information: Lot # C5370C02; Exp. 02/18
Quantity: 24 vials
Status: Terminated
Products in this recall event:
- Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1 (D-0799-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.