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 (14 patches per box) distributed nationwide because some batches contain elevated levels of impurities that exceed acceptable limits during the product's shelf life. The patches were distributed by Rugby Laboratories under NDC 0536-5895-88. This is a Class III recall, meaning the product is unlikely to cause serious health problems but does not meet quality standards.
- 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/6a350fb1-b6c7-4715-aaf8-9d28ed4c0363