FDA-Drug2025-04-16Class II

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

ASEGUA THERAPEUTICS LLC
Hazard

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

Sold states
US Nationwide
Affected count
18,541 cartons.
Manufactured in
333 Lakeside Dr, N/A, Foster City, CA, United States
Products
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

Official notice

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

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