Recall archive / FDA drug enforcement
Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, ea... — FDA record D-1166-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 23, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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).
- Classification
- Class I
- Recalling firm
- Akcea Therapeutics, Inc.
- Quantity
- 450 cartons
- Agency-reported status
- Terminated
- Source record identifier
- D-1166-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lots: 028C21AB, 028C21AC, Exp. 05/2025 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
KY, USA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 6, 2022
- Recall initiation date
- May 23, 2022
- Center classification date
- Jun 27, 2022
- Termination date
- Apr 4, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.