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
D-0799-2016
Product summary
- Event
- Event 72929
- Status
- Terminated
- Classification
- Class III
- Quantity
- 24 vials
- Official record key
drug-enforcement:D-0799-2016
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Code information: Lot # C5370C02; Exp. 02/18
Distribution pattern: TN
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing