D-1166-2022 Class I Terminated
FDA drug recall D-1166-2022 was initiated by Akcea Therapeutics, Inc. on May 23, 2022 and is designated Class I. Reason for recall: Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). The recall status is terminated (terminated April 4, 2023). Affected quantity: 450 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- July 6, 2022
- Initiation Date
- May 23, 2022
- Termination Date
- April 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 450 cartons
Product Description
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).
Distribution Pattern
KY, USA
Code Information
Lots: 028C21AB, 028C21AC, Exp. 05/2025