CLASS III Drug recall · Reported 6 Apr 2016 · FDA Enforcement Report
Lumizyme (alglucosidase alpha), 50 mg/vial recalled by Genzyme
Genzyme is recalling Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, distributed in Tennessee. The recall was initiated on 8 Dec 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0799-2016
- FDA event ID
- 72929
- Recalling firm
- Genzyme, Cambridge, MA
- Brand
- Lumizyme
- Manufacturer
- Genzyme Corporation
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Dec 2015
- FDA classified
- 31 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Dec 2015 | Recall initiated by company | |
| 31 Mar 2016 | Classified by FDA | +114 days |
| 6 Apr 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Product as listed by the FDA
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1
Where it was distributed
TN
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
Which lots are affected?
Lot # C5370C02; Exp. 02/18
Where was it sold?
TN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Genzyme
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Clolar (clofarabine) 20 mg/ (1 mg/mL) Injection, for intravenous use recalled | Genzyme | Packaging Defects | Nationwide |
| Drug | CLASS II | Thyrogen (thyrotropin alfa for injection) recalled by Genzyme | Genzyme | Particulate Matter | Nationwide |
| Drug | CLASS II | Thyrogen (thyrotropin alfa for injection) recalled by GenzymeThyrogen | Genzyme | Particulate Matter | Nationwide |
| Device | CLASS II | seprafilm¿ Single Site Adhesion Barrier Re recalled by Genzyme | Genzyme | Sterility | Nationwide |
| Device | CLASS II | seprafilm¿ Procedure Pack Adhesion Barrier Re recalled by Genzyme | Genzyme | Sterility | Nationwide |