D-142-2013 Class III Terminated
FDA drug recall D-142-2013 was initiated by Warner Chilcott Company LLC on December 21, 2012 and is designated Class III. Reason for recall: Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles The recall status is terminated (terminated June 16, 2015). Affected quantity: 3155 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 6, 2013
- Initiation Date
- December 21, 2012
- Termination Date
- June 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3155 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
Reason for Recall
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Distribution Pattern
US Nationwide
Code Information
0.45 mg: 505969A