PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: April 16, 2025 Initiated: March 7, 2025 #D-0313-2025

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.

Details

Recalling Firm
ASEGUA THERAPEUTICS LLC
Units Affected
18,541 cartons.
Distribution
US Nationwide
Location
Foster City, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by ASEGUA THERAPEUTICS LLC. Units affected: 18,541 cartons..
Why was this product recalled?
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 16, 2025. Severity: Moderate. Recall number: D-0313-2025.