Status
Completed
Drug Enforcement D-0246-2025
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Classification
Class II
Report Date
March 5, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 4944 cartons
- Reason for recall
- Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Padagis US LLC
- Address
-
3940 Quebec Ave N, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0246-2025
- Event ID
- 96245
- Recall initiation date
- February 6, 2025
- Center classification date
- February 21, 2025
- Code info
- Lot # 193109; Exp. 07/31/2026
- More code info
- —