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
D-0246-2025
Product summary
- Firm
- Padagis US LLC
- Event
- Event 96245
- Status
- Completed
- Classification
- Class II
- Quantity
- 4944 cartons
- Official record key
drug-enforcement:D-0246-2025
Official wording
Reason: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Code information: Lot # 193109; Exp. 07/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.