# FDA recall D-0799-2016

> **Genzyme Corporation** · Class III · drug recall initiated 2015-12-08.

## 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

- **Recall number:** D-0799-2016
- **Recalling firm:** Genzyme Corporation
- **Classification:** Class III
- **Product type:** drug
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0799-2016

## Citation

> AI Analytics. FDA recall D-0799-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0799-2016. Source: US FDA. Licensed CC0.

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