Recalls / Class III
Class IIID-0799-2016
Product
Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1
- Brand name
- Lumizyme
- Generic name
- Alglucosidase Alfa
- Active ingredient
- Alglucosidase Alfa
- Route
- Intravenous
- NDC
- 58468-0160
- FDA application
- BLA125291
- Affected lot / code info
- Lot # C5370C02; Exp. 02/18
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm
- Firm
- Genzyme Corporation
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 500 Kendall Street, 675 West Kendall/55 Cambridge Parkway, Cambridge, Massachusetts 02142-1108
Distribution
- Quantity
- 24 vials
- Distribution pattern
- TN
Timeline
- Recall initiated
- 2015-12-08
- FDA classified
- 2016-03-31
- Posted by FDA
- 2016-04-06
- Terminated
- 2016-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0799-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.