Recalls / Class III
Class IIID-141-12013
Product
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
- Affected lot / code info
- 0.9 mg: 512348A
Why it was recalled
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Recalling firm
- Firm
- Warner Chilcott Company LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Road 195, Km 1.1, Union Street, Fajardo, Puerto Rico 00738
Distribution
- Quantity
- 5439 bottles
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2012-12-21
- FDA classified
- 2013-01-31
- Posted by FDA
- 2013-02-06
- Terminated
- 2015-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-141-12013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.