ASEGUA THERAPEUTICS LLC recalls Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Th…

Recall date

March 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0313-2025

FDA classification

Class II

Brand / firm

ASEGUA THERAPEUTICS LLC

Sold / distributed

US Nationwide

Why it was recalled

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1