May 2022 FDA Recall Drug by Akcea Therapeutics, Inc.
D-1166-2022 - Superpotent
This Class I drug recall was voluntarily initiated by Akcea Therapeutics, Inc. on May 23, 2022 for the product Drug. The FDA reported the reason for recall as superpotent. The product was distributed in KY, USA and the recall is currently terminated.
Recall Number: D-1166-2022
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
05-23-2022
07-06-2022
450 cartons
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akcea Therapeutics, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
KY, USA
04-04-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lots: 028C21AB, 028C21AC, Exp. 05/2025
