Genzyme Corporation / Genzyme Biosurgery

FDA Regulatory Profile

Genzyme Corporation / Genzyme Biosurgery appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1518-2016, Class III) was initiated on August 4, 2016.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1518-2016Class IIIMozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous InjectionAugust 4, 2016
D-1029-2016Class IIIHectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery CorporApril 27, 2016