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  3. Recall Enforcement Event ID: 71656

Recall Enforment Report D-1236-2015

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Kremers Urban Pharmaceuticals, Inc., originally initiated on 07-07-2015 for the product 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 The product was recalled due to failed impurities/degradation specifications: failed specification for unknown impurity at the 24 month stability testing.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1236-201507-07-201507-22-2015Class II16,832 BoxesNitroglycerin 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 62175-123-01Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.Terminated
D-1237-201507-07-201507-22-2015Class II16,504 BoxesNitroglycerin Transdermal System 0.4 mg/hr (18 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 62175-124-01Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.Terminated