← FDA ENFORCEMENT
D-0313-2025Class II

ASEGUA THERAPEUTICS LLC

Recalling firm
ASEGUA THERAPEUTICS LLC
Product type
Drug
Status
Ongoing
Report date
2025-04-16
Distribution
US Nationwide
Firm state
CA
Product quantity
18,541 cartons.
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Code / lot info

Lot# 24ASV002UA, Exp Date: 6/30/2028

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.