SOFOSBUVIR Recall D-0313-2025
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
SOFOSBUVIR Recall D-0313-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0313-2025 |
| Event ID | 96434 |
| Brand | SOFOSBUVIR AND VELPATASVIR |
| Generic Name | VELPATASVIR AND SOFOSBUVIR |
| Manufacturer | VELPATASVIR AND SOFOSBUVIR |
| Original Package? | 1 |
| Active Substance | SOFOSBUVIR VELPATASVIR |
| Drug Route | ORAL |
| Distribution | US Nationwide |
| Quantity | 18,541 cartons. |
| Recall Reason | Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton. |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 72626-2701 |
| Product NUI | N0000191493 N0000191258 N0000191256 |
| Pharma Class (EPC) | Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC] |
| Recall Initiation Date | 20250307 |
| Report Date | 20250416 |
| Classification Date | 20250407 |
| Address | 333 Lakeside DrN/A Foster City, CA 94404-1147 United States |
| Recalling Firm | ASEGUA THERAPEUTICS LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | WJ6CA3ZU8B KCU0C7RS7Z |
| Drug Application Number | NDA208341 |
| Structured Product Labeling (SPL ID) | 314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d |
| Structured Product Labeling (SPL Set ID) | d0c1a945-4440-4b5c-81aa-693ed3db597c |
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