FDA recall D-1166-2022

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

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

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