Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01

Recall Number: D-1236-2015

Firm: Kremers Urban Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20150722

Initiation Date: 20150707

Termination Date: 20160212

Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.

Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01