FDA recall D-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

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-07-07

Report date

2015-07-22

Termination date

2016-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Seymour, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1237-2015