Eagle Pharmaceuticals Inc.

FDA Regulatory Profile

Eagle Pharmaceuticals Inc. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1429-2012, Class I) was initiated on December 2, 2011.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1429-2012Class IArgatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use VialDecember 2, 2011