FDAFDA · Food and drugs·Recall number D-1237-2015
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
Published July 22, 2015 · Recall initiated: July 7, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kremers Urban Pharmaceuticals, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: 5267504, Exp 07/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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