Recalls / Class II
Class IID-1237-2015
Product
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
- Affected lot / code info
- Lot #: 5267504, Exp 07/2015
Why it was recalled
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Recalling firm
- Firm
- Kremers Urban Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1101 C Ave W, N/A, Seymour, Indiana 47274-3342
Distribution
- Quantity
- 16,504 Boxes
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-07-07
- FDA classified
- 2015-07-14
- Posted by FDA
- 2015-07-22
- Terminated
- 2016-02-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1237-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.