Aveva Drug Delivery Systems, Inc.: Nicotine Transdermal System Patch, 14 Mg, 14 Patches Per Box, Aveva
AVEVA is recalling Nicotine Transdermal System Patch (14 mg) distributed nationwide because some patches contain elevated levels of impurities that exceed acceptable limits during their shelf life. The affected product is Aveva brand nicotine patches in boxes of 14, distributed by Rugby Laboratories. This is a Class III recall, the least serious classification, affecting consumers across all U.S. states and Washington, D.C.
- Recalling firm
- AVEVA Drug Delivery Systems, Inc.
- Product
- 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.
- Reason
- Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
- Classification
- Class III
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/008c13ab-b864-461e-ae26-7a667ee4ef3b