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
Reason for recall: Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Recall initiated: 20220523
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated