FDA Drug recall 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 o…
- FDA Drug
- Class I
- terminated
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class I recall of Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg o… by Akcea Therapeutics, citing superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1166-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-05-23 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akcea Therapeutics |
| Distribution | KY |
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
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Identifiers
| code_info | Lots: 028C21AB, 028C21AC, Exp. 05/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1166-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.