FDA Drug recall D-1237-2015
Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kre…
- FDA Drug
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kre… by Kremers Urban Pharmaceuticals, citing failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1237-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-07 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Kremers Urban Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Identifiers
| code_info | Lot #: 5267504, Exp 07/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1237-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.