FDA Drug recall D-0799-2016
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 021…
- FDA Drug
- Class III
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class III recall of Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 021… by Genzyme, citing labeling: Incorrect or Missing Lot and/or Exp Date.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0799-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-12-08 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Genzyme |
| Distribution | TN |
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
Labeling: Incorrect or Missing Lot and/or Exp Date
Identifiers
| ndc | 58468-0160-1 |
|---|---|
| ndc | 58468-0160-2 |
| code_info | Lot # C5370C02; Exp. 02/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0799-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.