FDA Drugs recall ·
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets… recall
Read the official FDA notice ↗
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
Why was it recalled?
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 24ASV002UA, Exp Date: 6/30/2028
Distribution
US Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0313-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.