Class IIIOngoing

Estradiol Transdermal System recall

FDA recall D-0543-2024 · initiated May 16, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Failed Impurities/Degradation Specifications.

Details

Product: Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
Recalling company: Zydus Pharms USA
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: May 16, 2024
FDA report date: Jun 12, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0543-2024 ↗

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