Akcea Therapeutics, Inc. recalls Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each…

Recall date

May 23, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1166-2022

FDA classification

Class I

Brand / firm

Akcea Therapeutics, Inc.

Sold / distributed

KY, USA

Why it was recalled

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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