Why it was recalled
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
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
Lot numbers, UPCs & expiration codes
Lot# 24ASV002UA, Exp Date: 6/30/2028
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0313-2025
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 7, 2025
- FDA report date
- Apr 16, 2025
- Quantity
- 18,541 cartons.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ASEGUA THERAPEUTICS LLC
Original FDA data
Every field from FDA enforcement report D-0313-2025, exactly as published.
Show all FDA fields
- City
- Foster City
- State
- CA
- Status
- Completed
- Country
- United States
- Event ID
- 96434
- Address
- 333 Lakeside Dr
- Code information
- Lot# 24ASV002UA, Exp Date: 6/30/2028
- Postal code
- 94404-1147
- Report date
- Apr 16, 2025
- Product type
- Drugs
- Recall number
- D-0313-2025
- Classification
- Class II
- Recalling firm
- ASEGUA THERAPEUTICS LLC
- Product quantity
- 18,541 cartons.
- Reason for recall
- Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- US Nationwide
- Recall initiation date
- Mar 7, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 7, 2025