D-0542-2024 Class III Ongoing
FDA drug recall D-0542-2024 was initiated by Zydus Pharmaceuticals (USA) Inc on May 16, 2024 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications. The recall status is ongoing. Affected quantity: 21,360 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 12, 2024
- Initiation Date
- May 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,360 units
Product Description
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: M310493, Exp. Date 01/2025; M308397, Exp. Date 11/2024; M305337, Exp. Date 10/2024; M400155, Exp. Date 06/2025; M314660, Exp. Date 05/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0542-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026