Drug product
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
D-822-2013
Product summary
- Event
- Event 65461
- Status
- Terminated
- Classification
- Class II
- Quantity
- 188,600 bottles
- Official record key
drug-enforcement:D-822-2013
Official wording
Reason: Failed Impurities/Degradation Specifications: unspecified degradation product
Code information: Lot F1002 - Exp.12/13
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications