Femtrace 0.45 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

Recall Number: D-142-2013

Firm: Warner Chilcott Company LLC

Classification: Class III

Status: Terminated

Report Date: 20130206

Initiation Date: 20121221

Termination Date: 20150616

Reason for Recall

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

Product Description

Femtrace 0.45 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

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