Data Composite

Recall D-0246-2025

US Class II Completed · initiated 2025-02-06

Recalling firm

Padagis US LLC, MN

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.

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