Akcea Therapeutics, Inc.: Drug Recall
Recall #D-1166-2022 · 05/23/2022
Class I: Dangerous
Recall Details
- Recall Number
- D-1166-2022
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Akcea Therapeutics, Inc.
- Status
- Terminated
- Date Initiated
- 05/23/2022
- Location
- Carlsbad, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 450 cartons
Reason for Recall
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
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
Distribution Pattern
KY, USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.