Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics ...
FDA Recall #D-141-12013 — Class III — December 21, 2012
Product Description
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
Reason for Recall
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Recalling Firm
Warner Chilcott Company LLC — Fajardo, PR
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
5439 bottles
Distribution
US Nationwide
Code Information
0.9 mg: 512348A
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated