Drug 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
D-1166-2022
Product summary
- Event
- Event 90245
- Status
- Terminated
- Classification
- Class I
- Quantity
- 450 cartons
- Official record key
drug-enforcement:D-1166-2022
Official wording
Reason: Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Code information: Lots: 028C21AB, 028C21AC, Exp. 05/2025
Distribution pattern: KY, USA
Derived failure modes
-
Potency or specification failure
Superpotent