Status
Ongoing
Drug Enforcement D-0313-2025
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Classification
Class II
Report Date
April 16, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 18,541 cartons.
- Reason for recall
- Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide
Location & Firm
- Recalling firm
- ASEGUA THERAPEUTICS LLC
- Address
-
333 Lakeside Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0313-2025
- Event ID
- 96434
- Recall initiation date
- March 7, 2025
- Center classification date
- April 7, 2025
- Code info
- Lot# 24ASV002UA, Exp Date: 6/30/2028
- More code info
- —