Akcea Therapeutics, Inc.

FDA Regulatory Profile

Akcea Therapeutics, Inc. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (D-1166-2022, Class I) was initiated on May 23, 2022.

Summary

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

Recent Recalls

NumberClassProductDate
D-1166-2022Class ITegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefiMay 23, 2022