Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90245

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 23, 2022
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Akcea Therapeutics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01

D-1166-2022
Recall number
D-1166-2022
Initiated
May 23, 2022
Classification
Class I
Status
Terminated
Recalling firm
Akcea Therapeutics, Inc.
Quantity
450 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

Code information

Lots: 028C21AB, 028C21AC, Exp. 05/2025

Distribution pattern

KY, USA