Reported Feb 6, 2013 · Terminated
Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc,…
Warner Chilcott Company LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Warner Chilcott Company LLC · Road 195, Km 1.1 · Fajardo, PR · 00738
Is this the product you have?
- 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
- Lot codes and dates
- 0.9
- mg512348A
- Amount recalled
- 5439 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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