Superpotent Injection Under Class I Recall

A recall for 450 cartons of Tegsedi (inotersen) injection has been designated Class I by the US Food and Drug Administration. According to the FDA’s July 6, 2022, Enforcement Report, the recall followed a test result suggesting superpotency of the injection. A Class I designation is the most serious recall classification and warns that use of the affected product could cause serious adverse health consequences or death.

The recall affects Tegsedi injection, 284 mg/1.5 mL, 4 prefilled syringes per carton (NDC 72126-007-01), from lots 028C21AB and 028C21AC (Exp. 5/25). The medication was distributed by Sobi Inc, Waltham, MA, in Kentucky.

Akcea Therapeutics voluntarily initiated the recall May 23, 2022. The FDA designated the recall Class I on June 27, 2022.

Tegsedi is a prescription medication used to treat nerve problems caused by hereditary transthyretin-mediated amyloidosis.