United StatesNicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva (distributed by Rugby Laboratories, Indianapolis, IN), NDC 0536-5895-88, Lot #56841, expires 03/2028, sold nationwide in the U.S. is affected. It was recalled after stability testing found elevated oxidative-related impurities that exceed shelf-life specifications.
What's being recalled
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.
Recalling firm: AVEVA Drug Delivery Systems, Inc., Miramar, FL, United States.
How to identify it
Lot #: 56841, Expires: 03/2028
The hazard
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the U.S
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)