FDA DrugClass IIINotable

FDA Recall: Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATOR

Date: 2026-06-03
Brand: AVEVA Drug Delivery Systems, Inc.
Category: Drug
FDA Class: Class III

Description

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

Hazard

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

Remedy

59,808 pouches (4,272 Individual Folding Carton (IFC))

Related Recalls