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Genzyme Corporation

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
6
Inspections
26
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0075-2018Class IIIClolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva POctober 12, 2017
D-0729-2016Class IIThyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injectiFebruary 16, 2016
D-0730-2016Class IIThyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injectiFebruary 16, 2016
D-0799-2016Class IIILumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by December 8, 2015
Z-1856-2012Class IIseprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm AdhesJune 13, 2012
Z-1855-2012Class IIseprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm June 13, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K102242OSOM C. DIFFICILE TOXIN A/B TESTDecember 21, 2010
K092633OSOM INFLUENZA A&B TEST , MODEL PN190September 25, 2009
K080662GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATORMay 15, 2008
K063739SEPRAMESH, MODEL 5959-1214January 17, 2007
K053066SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESHDecember 19, 2005
K043035SEPRAGEL ENT BIORESORBABLE PACKING/STENTJuly 11, 2005