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Recall Observatory FDA recall evidence

Drug product

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

D-0542-2024

May 16, 2024

Class III

Product summary

Firm
Zydus Pharmaceuticals (USA) Inc
Event
Event 94649
Status
Ongoing
Classification
Class III
Quantity
21,360 units
Official record key
drug-enforcement:D-0542-2024

Official wording

Reason: Failed Impurities/Degradation Specifications.

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

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications