FDA recall D-0246-2025

Padagis US LLC · Class II · drug

Product

Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30

Reason for recall

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

Distribution

Nationwide in the USA

Key facts

Status
Completed
Initiation date
2025-02-06
Report date
2025-03-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2025