# FDA recall D-1166-2022

> **Akcea Therapeutics, Inc.** · Class I · drug recall initiated 2022-05-23.

## Product

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).

## Distribution

KY, USA

## Key facts

- **Recall number:** D-1166-2022
- **Recalling firm:** Akcea Therapeutics, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-23
- **Report date:** 2022-07-06
- **Termination date:** 2023-04-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1166-2022

## Citation

> AI Analytics. FDA recall D-1166-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1166-2022. Source: US FDA. Licensed CC0.

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