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.

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