# Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. — FDA Safety Label Change

> Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

**Manufacturer:** AVEVA Drug Delivery Systems, Inc.
**Date of action:** 20260603
**Canonical URL:** https://drugsmonitor.com/recall/08987bdc-e512-42a8-81cf-16391eec68ad
**Last updated:** 2026-06-11

## Summary

Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. (AVEVA Drug Delivery Systems, Inc.) — Safety Label Change on 20260603.

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

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*Educational recall record from DrugsMonitor.com. Confirm details with FDA primary sources.*