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
FDA recall notice · announced August 7, 2013 · Warner Chilcott Us
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
Failed Impurities/Degradation Specifications: unspecified degradation product
Notes
Distribution: Nationwide
Lot/code information: Lot F1002 - Exp.12/13
Quantity: 188,600 bottles
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.