Tegsedi — Class I drug recall D-1166-2022
Terminated recall by Akcea Therapeutics, Inc., reported 2022-07-06, distributed in KY. Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
| Recall number | D-1166-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akcea Therapeutics, Inc., Carlsbad, CA, United States |
| Recall initiated | 2022-05-23 |
| Classified | 2022-06-27 |
| Reported by FDA | 2022-07-06 |
| Terminated | 2023-04-04 |
| Distributed | KY |
| Quantity | 450 cartons |
| Reason classes | labeling, potency, specification failure |
| NDC | 72126-0007-01 |
| Lot numbers | 028C21AB, 028C21AC |
| Expiration dates | 2025-05 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1166-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.