# FDA recall D-1237-2015

> **Kremers Urban Pharmaceuticals, Inc.** · Class II · drug recall initiated 2015-07-07.

## 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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1237-2015
- **Recalling firm:** Kremers Urban Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-07
- **Report date:** 2015-07-22
- **Termination date:** 2016-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Seymour, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1237-2015

## Citation

> AI Analytics. FDA recall D-1237-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1237-2015. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
