Sofosbuvir And Velpatasvir Tablet, Film Coated
FDA Recall NDC 72626-2701
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
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 recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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
Ongoing
Recalling Firm
ASEGUA THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
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
72626-2701-1Product
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.
