FDA-Drug2015-07-22Class II
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
Kremers Urban Pharmaceuticals, Inc.
Hazard
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Sold states
Nationwide and Puerto Rico
Affected count
16,504 Boxes
Manufactured in
1101 C Ave W, N/A, Seymour, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1237-2015Don't want to check this manually?
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