Lumizyme — Class III drug recall D-0799-2016
Terminated recall by Genzyme Corporation, reported 2016-04-06, distributed in TN. Labeling: Incorrect or Missing Lot and/or Exp Date
| Recall number | D-0799-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genzyme Corporation, Cambridge, MA, United States |
| Recall initiated | 2015-12-08 |
| Classified | 2016-03-31 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2016-08-01 |
| Distributed | TN |
| Quantity | 24 vials |
| Reason classes | labeling |
| NDC | 58468-0160, 58468-0160-01, 58468-0160-02 |
| Lot numbers | 02/18, C5370C02 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0799-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.