ASEGUA THERAPEUTICS LLC: Drug Recall

Recall #D-0313-2025 · 03/07/2025

Class II: Risk

Recall Details

Recall Number
D-0313-2025
Classification
Class II
Product Type
Drug
Recalling Firm
ASEGUA THERAPEUTICS LLC
Status
Ongoing
Date Initiated
03/07/2025
Location
Foster City, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,541 cartons.

Reason for Recall

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

Product Description

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

Distribution Pattern

US Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.