FDA Drug Class I — Most Serious

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

Hazard

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

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Products

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
Brand
Akcea Therapeutics, Inc.
UPC
Lots: 028C21AB, 028C21AC, Exp. 05/2025

Units Affected

450 cartons

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