FDA-Drug2013-08-07Class II
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
Warner Chilcott US LLC
Hazard
Failed Impurities/Degradation Specifications: unspecified degradation product
Sold states
Nationwide
Affected count
188,600 bottles
Manufactured in
100 Enterprise Dr, N/A, Rockaway, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-822-2013Don't want to check this manually?
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