Drug product
Nitroglycerin 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 62175-124-01
D-1237-2015
Product summary
- Event
- Event 71656
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,504 Boxes
- Official record key
drug-enforcement:D-1237-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Code information: Lot #: 5267504, Exp 07/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications