Kremers Urban Pharmaceuticals, Inc. recalls Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, M…
- Recall date
- July 7, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1236-2015
- FDA classification
- Class II
- Brand / firm
- Kremers Urban Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever Kremers Urban Pharmaceuticals, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Kremers Urban Pharmaceuticals, Inc.