Drug recall
Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled…
FDA recall event 90245 · Class I · Akcea Therapeutics, Inc.
Key facts
| Event ID | 90245 |
|---|---|
| Recall numbers | D-1166-2022 |
| Recalling firm | Akcea Therapeutics, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). |
| Initiation date | May 23, 2022 |
| Report date | Jul 6, 2022 |
| Termination date | Apr 4, 2023 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 3015007621 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: