FDA recall D-0313-2025

ASEGUA THERAPEUTICS LLC · Class II · drug

Product

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

Reason for recall

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

Distribution

US Nationwide

Key facts

Status
Ongoing
Initiation date
2025-03-07
Report date
2025-04-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Foster City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0313-2025