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

FDA recall notice · announced July 6, 2022 · Akcea Therapeutics

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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).

Notes

Distribution: KY, USA
Lot/code information: Lots: 028C21AB, 028C21AC, Exp. 05/2025
Quantity: 450 cartons
Status: Terminated
Products in this recall event:
- 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 (D-1166-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.