Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua The
Summary
The FDA issued a Class II for Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister card by ASEGUA THERAPEUTICS LLC. Reason: Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton..
Details
Source
Drug Recall
External ID
D-0313-2025
Action Date
2025-04-16
Status
Ongoing
Category
drug
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/Code Info: Lot# 24ASV002UA, Exp Date: 6/30/2028
Quantity Affected: 18,541 cartons.
Reason for Recall
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-07
Company
Foster City, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 86 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ASEGUA THERAPEUTICS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ASEGUA THERAPEUTICS LLC have FDA actions?
This is the only FDA action we have on record for ASEGUA THERAPEUTICS LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0313-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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