Recall: D-0543-2024

Class III - Minor Violations

Class IIIClassification

2024-05-16Initiated

OngoingStatus

Zydus Pharmaceuticals (USA) InFirm

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

Reason

Failed Impurities/Degradation Specifications.

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.