⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

AVEVA Drug Delivery Systems, Inc.: Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorph

DrugsSource: FDA (drug) · Date: 2026-06-03

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
AVEVA Drug Delivery Systems, Inc.
Product
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.
Reason / hazard
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide within the U.S
Recall initiated
2026-05-14
Code info
Lot #: 56841, Expires: 03/2028
Product quantity
59,808 pouches (4,272 Individual Folding Carton (IFC))
Voluntary mandated
Voluntary: Firm initiated
City
Miramar
State
FL
Country
United States
Event id
98972
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