Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
What was recalled
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
- Recalling firm
- Akcea Therapeutics, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1166-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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