Sofosbuvir And Velpatasvir Tablet, Film Coated
FDA Recall NDC 72626-2701
Latest: Class II · Status: Terminated · Initiated Mar 07, 2025 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sofosbuvir And Velpatasvir (NDC 72626-2701). A significant event, classified as Class II, was initiated on Mar 07, 2025 by Asegua Therapeutics Llc. The reported reason for this action was: "Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Mar 07, 2025
Apr 16, 2025
18,541 cartons.
Recall Profile & Regulatory Data
Event ID
96434
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
ASEGUA THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Sep 29, 2026
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
Batch or Lot Expiration Information
Lot# 24ASV002UA, Exp Date: 6/30/2028
Affected Packages Involved in this Recall
72626-2701-1Sofosbuvir And Velpatasvir
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
