FDA recall D-0799-2016
Genzyme Corporation · Class III · drug
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
Distribution
TN
Key facts
- Status
- Terminated
- Initiation date
- 2015-12-08
- Report date
- 2016-04-06
- Termination date
- 2016-08-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Cambridge, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0799-2016