Drug recall
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme…
FDA recall event 72929 · Class III · Genzyme Corporation
Key facts
| Event ID | 72929 |
|---|---|
| Recall numbers | D-0799-2016 |
| Recalling firm | Genzyme Corporation |
| Product type | Drugs |
| Products | Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Incorrect or Missing Lot and/or Exp Date |
| Initiation date | Dec 8, 2015 |
| Report date | Apr 6, 2016 |
| Termination date | Aug 1, 2016 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 1221955 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: