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
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Classification
Class I
Status
Terminated
Lot
Lots: 028C21AB, 028C21AC, Exp. 05/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Akcea Therapeutics, Inc. — Class I Recall | MedicineWatch US