Drug 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
D-0313-2025
Product summary
- Event
- Event 96434
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,541 cartons.
- Official record key
drug-enforcement:D-0313-2025
Official wording
Reason: Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Code information: Lot# 24ASV002UA, Exp Date: 6/30/2028
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.