Recalls / Class II
Class IID-0313-2025
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
- Brand name
- Sofosbuvir And Velpatasvir
- Generic name
- Velpatasvir And Sofosbuvir
- Active ingredients
- Sofosbuvir, Velpatasvir
- Route
- Oral
- NDC
- 72626-2701
- FDA application
- NDA208341
- Affected lot / code info
- Lot# 24ASV002UA, Exp Date: 6/30/2028
Why it was recalled
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Recalling firm
- Firm
- ASEGUA THERAPEUTICS LLC
- Manufacturer
- Asegua Therapeutics LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 333 Lakeside Dr, N/A, Foster City, California 94404-1147
Distribution
- Quantity
- 18,541 cartons.
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2025-03-07
- FDA classified
- 2025-04-07
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0313-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.