Official recall notice
FDA DrugClass IIINotable
FDA Recall: Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATOR
- Recall date
- 2026-06-03
- Category
- Drug
- FDA class
- Class III
Why it was recalled
Hazard
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Recommended action
What to do
59,808 pouches (4,272 Individual Folding Carton (IFC))
Product description
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.