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
This recall is currently active, issued April 16, 2025. It was issued by Asegua Therapeutics Llc.
- Company
- Asegua Therapeutics Llc
- Recall Initiated
- March 7, 2025
- Posted
- April 16, 2025
- Recall Number
- D-0313-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 18,541 cartons.
- Firm Location
- Foster City, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Distribution
US Nationwide
Lot / Code Info
Lot# 24ASV002UA, Exp Date: 6/30/2028
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