US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 7, 2015 (11 years ago)

Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.

What was recalled

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

Recalling firm
Kremers Urban Pharmaceuticals, Inc.
NDC code
62175-124-01
Origin
IN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1237-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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