Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Recall Number: D-0527-2021

Firm: Cardinal Health Inc.

Classification: Class II

Status: Terminated

Report Date: 20210602

Initiation Date: 20210315

Termination Date: 20240617

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.