RecallDepth
Class I Terminated

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

Company
Akcea Therapeutics, Inc.
Recall Initiated
May 23, 2022
Posted
July 6, 2022
Recall Number
D-1166-2022
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
450 cartons
Firm Location
Carlsbad, CA, United States

Reason for Recall

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

Distribution

KY, USA

Lot / Code Info

Lots: 028C21AB, 028C21AC, Exp. 05/2025

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