Akcea Therapeutics, Inc. recalls Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each
Recalled July 6, 2022 · FDA recall D-1166-2022 · Akcea Therapeutics
Hazard
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). · FDA Class I
Units
450 cartons
Sold at
KY, USA
Description
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
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
Manufacturer(s)
Akcea Therapeutics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →