Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manuf...
FDA Recall #D-0313-2025 — Class II — March 7, 2025
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
Reason for Recall
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Recalling Firm
ASEGUA THERAPEUTICS LLC — Foster City, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
18,541 cartons.
Distribution
US Nationwide
Code Information
Lot# 24ASV002UA, Exp Date: 6/30/2028
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated