DrugJul 6, 2022
Akcea Therapeutics Tegsedi (inotersen) Injection 284 mg/1.5 mL recall — FDA D-1166-2022
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Class IFDA: TerminatedAkcea Therapeutics, Inc.
Recall history in this database
Classification mix: Class I: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies Akcea Therapeutics, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.