Kremers Urban Pharmaceuticals, Inc.

FDA Regulatory Profile

Kremers Urban Pharmaceuticals, Inc. appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1236-2015, Class II) was initiated on July 7, 2015.

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