Carlsbad, CA, United States
Akcea Therapeutics, Inc. recalls
1 recall recorded since 2018, most recently on 23 May 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 23 May 2022
- Terminated
- 4 April 2023
- Reason
- Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
- Distribution
- KY, USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1166-2022
- 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), Distr
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.