FDA-Drug2024-06-12Class III

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

Zydus Pharmaceuticals (USA) Inc
Hazard

Failed Impurities/Degradation Specifications.

Sold states
Nationwide within the United States
Affected count
13,440 units
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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

Official notice

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

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