Akcea Therapeutics, Inc. Recalls

FDA
1
Total Recalls
1
Agencies
Jul 2022
First Recall
Jul 2022
Latest Recall

Showing 1-1 of 1 recalls

FDA

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

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).