FDAFDA · Food and drugs·Recall number D-0542-2024
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
Published June 12, 2024 · Recall initiated: May 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ESTRADIOL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide within the United States
- UPC
- 0370710119188
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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