D-0313-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2025
- Initiation Date
- March 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,541 cartons.
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.
Distribution Pattern
US Nationwide
Code Information
Lot# 24ASV002UA, Exp Date: 6/30/2028