D-0246-2025 Class II
FDA drug recall D-0246-2025 was initiated by Padagis US LLC on February 6, 2025 and is designated Class II. Reason for recall: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. Affected quantity: 4944 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 5, 2025
- Initiation Date
- February 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4944 cartons
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot # 193109; Exp. 07/31/2026