Status
Terminated
Drug Enforcement D-822-2013
Failed Impurities/Degradation Specifications: unspecified degradation product
Classification
Class II
Report Date
August 7, 2013
Termination Date
November 30, 2015
Product Information
- Product description
- Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07
- Product quantity
- 188,600 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: unspecified degradation product
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Warner Chilcott US LLC
- Address
-
100 Enterprise Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-822-2013
- Event ID
- 65461
- Recall initiation date
- May 17, 2013
- Center classification date
- July 26, 2013
- Code info
- Lot F1002 - Exp.12/13
- More code info
- —