Recall
FDAHealthMarch 7, 2025

ASEGUA THERAPEUTICS LLC — 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., F

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 7, 2025

US Nationwide

What's affected?

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
Lot code
24ASV002UA

Additional details

Lot# 24ASV002UA, Exp Date: 6/30/2028

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 18,541 cartons..

View original FDA notice →

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