FDA-Drug2013-02-06Class III

Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738

Warner Chilcott Company LLC
Hazard

Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

Sold states
US Nationwide
Affected count
5439 bottles
Manufactured in
Road 195, Km 1.1, Union Street, Fajardo, PR, United States
Products
Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-141-12013

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