Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lots: 028C21AB, 028C21AC, Exp. 05/2025
Where it was sold
KY, USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1166-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 23, 2022
- FDA report date
- Jul 6, 2022
- Quantity
- 450 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akcea Therapeutics, Inc.
Original FDA data
Every field from FDA enforcement report D-1166-2022, exactly as published.
Show all FDA fields
- City
- Carlsbad
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 90245
- Address
- 2855 Gazelle Ct
- Code information
- Lots: 028C21AB, 028C21AC, Exp. 05/2025
- Postal code
- 92010-6670
- Report date
- Jul 6, 2022
- Product type
- Drugs
- Recall number
- D-1166-2022
- Classification
- Class I
- Recalling firm
- Akcea Therapeutics, Inc.
- Product quantity
- 450 cartons
- Termination date
- Apr 4, 2023
- Reason for recall
- Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- May 23, 2022
- Initial firm notification
- Center classification date
- Jun 27, 2022