INOTERSEN SODIUM Recall D-1166-2022
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
INOTERSEN SODIUM Recall D-1166-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1166-2022 |
| Event ID | 90245 |
| Brand | TEGSEDI |
| Generic Name | INOTERSEN |
| Manufacturer | INOTERSEN |
| Original Package? | 1 |
| Active Substance | INOTERSEN SODIUM |
| Drug Route | SUBCUTANEOUS |
| Distribution | KY, USA |
| Quantity | 450 cartons |
| Recall Reason | Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). |
| Drug Classification | Class I |
| Drug Code Info | 20220706 |
| Product NDC | 72126-007 |
| Recall Initiation Date | 20220523 |
| Report Date | 20220706 |
| Classification Date | 20220627 |
| Address | 2855 Gazelle Ct Carlsbad, CA 92010-6670 United States |
| Recalling Firm | Akcea Therapeutics, Inc. |
| Initial Notification | |
| Unique Ingredient Identifier | 950736UC77 |
| Drug Application Number | NDA211172 |
| Structured Product Labeling (SPL ID) | 096941de-9387-47b2-b717-918d2709ed37 |
| Structured Product Labeling (SPL Set ID) | 8513207e-b55f-417b-9473-af785146a543 |
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