March 2025 FDA Recall Sofosbuvir And Velpatasvir by Asegua Therapeutics Llc
D-0313-2025 - Defective Container
This Class II drug recall was voluntarily initiated by Asegua Therapeutics Llc on March 7, 2025 for the product Sofosbuvir And Velpatasvir. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0313-2025
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
03-07-2025
04-16-2025
18,541 cartons.
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
ASEGUA THERAPEUTICS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 24ASV002UA, Exp Date: 6/30/2028
