FDAFDA · Food and drugs·Recall number D-142-2013
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
Published February 6, 2013 · Recall initiated: December 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Warner Chilcott Company LLC
- Distributor
- US Nationwide
- Lot
- 0.45 mg: 505969A
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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