EMD Serono, Inc.

FDA Regulatory Profile

EMD Serono, Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1379-2020, Class II) was initiated on June 29, 2020.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1379-2020Class IICetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, June 29, 2020
D-1813-2015Class IIIClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) perSeptember 10, 2015