FDA recall D-822-2013

Warner Chilcott US LLC · Class II · 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

Reason for recall

Failed Impurities/Degradation Specifications: unspecified degradation product

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-05-17
Report date: 2013-08-07
Termination date: 2015-11-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockaway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-822-2013