D-822-2013 Class II Terminated
FDA drug recall D-822-2013 was initiated by Warner Chilcott US LLC on May 17, 2013 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: unspecified degradation product The recall status is terminated (terminated November 30, 2015). Affected quantity: 188,600 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2013
- Initiation Date
- May 17, 2013
- Termination Date
- November 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188,600 bottles
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
Reason for Recall
Failed Impurities/Degradation Specifications: unspecified degradation product
Distribution Pattern
Nationwide
Code Information
Lot F1002 - Exp.12/13