Status
Terminated
Drug Enforcement D-142-2013
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Classification
Class III
Report Date
February 6, 2013
Termination Date
June 16, 2015
Product Information
- 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
- Product quantity
- 3155 bottles
- Reason for recall
- Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide
Location & Firm
- Recalling firm
- Warner Chilcott Company LLC
- Address
-
Road 195, Km 1.1, Union Street
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-142-2013
- Event ID
- 64014
- Recall initiation date
- December 21, 2012
- Center classification date
- January 31, 2013
- Code info
- 0.45 mg: 505969A
- More code info
- —