FDAFDA · Food and drugs·Recall number D-1166-2022
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
Published July 6, 2022 · Recall initiated: May 23, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Akcea Therapeutics, Inc.
- Distributor
- KY, USA
- Lot
- Lots: 028C21AB, 028C21AC, Exp. 05/2025
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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