FDA recall D-0543-2024

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 for recall

Failed Impurities/Degradation Specifications.

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-05-16

Report date

2024-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0543-2024