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
Reported: July 6, 2022 Initiated: May 23, 2022 #D-1166-2022
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
Reason for Recall
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Details
- Recalling Firm
- Akcea Therapeutics, Inc.
- Units Affected
- 450 cartons
- Distribution
- KY, USA
- Location
- Carlsbad, CA
Frequently Asked Questions
What product 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. Recalled by Akcea Therapeutics, Inc.. Units affected: 450 cartons.
Why was this product recalled? ▼
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 6, 2022. Severity: Critical. Recall number: D-1166-2022.
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