D-1237-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 22, 2015
- Initiation Date
- July 7, 2015
- Termination Date
- February 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,504 Boxes
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 5267504, Exp 07/2015