Class III

Drug Recall: 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 0

Zydus Pharmaceuticals (USA) Inc · May 16, 2024

Reason for Recall

Failed Impurities/Degradation Specifications.

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

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

21,360 units

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0542-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.