Enforcement Report - Week of February 6, 2013
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Product Detail
| 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 |
|---|---|
| Recall Number | D-141-12013 |
| Classification | Class III |
| Code Info | 0.9 mg: 512348A |
| Product Distributed Qty | 5439 bottles |
| Reason For Recall | Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles |
Event Detail
| Event Id | 64014 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Warner Chilcott Company LLC |
| City | Fajardo |
| State | PR | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide |
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