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
Reported: July 22, 2015 Initiated: July 7, 2015 #D-1236-2015
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Details
- Recalling Firm
- Kremers Urban Pharmaceuticals, Inc.
- Units Affected
- 16,832 Boxes
- Distribution
- Nationwide and Puerto Rico
- Location
- Seymour, IN
Frequently Asked Questions
What product 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. Recalled by Kremers Urban Pharmaceuticals, Inc.. Units affected: 16,832 Boxes.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 22, 2015. Severity: Moderate. Recall number: D-1236-2015.
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