Class II
Terminated
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 Initiated
- July 7, 2015
- Posted
- July 22, 2015
- Recall Number
- D-1236-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,832 Boxes
- Firm Location
- Seymour, IN, United States
Reason for Recall
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: 5267605, Exp 08/2015
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