FDA Recall D-1166-2022
Akcea Therapeutics, Inc. · Carlsbad, CA
Class I — life-threatening Terminated 316 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Recall record
- Recall number
D-1166-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- KY, USA
- Recall initiated
- 2022-05-23
- Classified by FDA Center
- 2022-06-27
- FDA published
- 2022-07-06
- Terminated
- 2023-04-04
- Recalling firm
- Akcea Therapeutics, Inc.
- Firm location
- Carlsbad, CA