Low risk Filed 2026-06-03
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
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.
Check these codes: Lot #: 56841, Expires: 03/2028
59,808 pouches (4,272 Individual Folding Carton (IFC)) · distributed nationwide within the u.s Recall D-0550-2026 on FDA.gov ↗