Genzyme Corporation
FDA Regulatory Profile
Genzyme Corporation appears in FDA public data with 6 recalls, 6 510(k) clearances, 26 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0075-2018, Class III) was initiated on October 12, 2017. Its most recent 510(k) clearance was granted on December 21, 2010.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 6
- Inspections
- 26
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0075-2018 | Class III | Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva P | October 12, 2017 |
| D-0729-2016 | Class II | Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injecti | February 16, 2016 |
| D-0730-2016 | Class II | Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injecti | February 16, 2016 |
| D-0799-2016 | Class III | Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by | December 8, 2015 |
| Z-1855-2012 | Class II | seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm | June 13, 2012 |
| Z-1856-2012 | Class II | seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhes | June 13, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K102242 | OSOM C. DIFFICILE TOXIN A/B TEST | December 21, 2010 |
| K092633 | OSOM INFLUENZA A&B TEST , MODEL PN190 | September 25, 2009 |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | May 15, 2008 |
| K063739 | SEPRAMESH, MODEL 5959-1214 | January 17, 2007 |
| K053066 | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH | December 19, 2005 |
| K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT | July 11, 2005 |