Kremers Urban Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1236-2015Class IINitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) July 7, 2015
D-1237-2015Class IINitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) July 7, 2015
D-009-2014Class IIOmeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: September 16, 2013