Nitroglycerin Transdermal System 0 — Class II drug recall D-1237-2015
Terminated recall by Kremers Urban Pharmaceuticals, Inc., reported 2015-07-22, distributed nationwide. Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 mon
| Recall number | D-1237-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kremers Urban Pharmaceuticals, Inc., Seymour, IN, United States |
| Recall initiated | 2015-07-07 |
| Classified | 2015-07-14 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 16,504 boxes |
| Reason classes | specification failure |
| NDC | 62175-0124-01 |
| Lot numbers | 5267504 |
| Expiration dates | 2015-07 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1237-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.