Kremers Urban Pharmaceuticals, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
| D-1236-2015 | Class II | Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) | July 7, 2015 |
| D-1237-2015 | Class II | Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) | July 7, 2015 |
| D-009-2014 | Class II | Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: | September 16, 2013 |