Class I
Terminated
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
- Company
- Akcea Therapeutics, Inc.
- Recall Initiated
- May 23, 2022
- Posted
- July 6, 2022
- Recall Number
- D-1166-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 450 cartons
- Firm Location
- Carlsbad, CA, United States
Reason for Recall
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Distribution
KY, USA
Lot / Code Info
Lots: 028C21AB, 028C21AC, Exp. 05/2025
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