HIGH

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.

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

Quick Facts at a Glance

Recall Date
May 14, 2026
Hazard Level
HIGH
Brands
NICOTINE, Rugby Laboratories
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact AVEVA Drug Delivery Systems, Inc. or your healthcare provider for guidance. Notification method: Letter

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Full Description

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.. Generic: NICOTINE; Brand: NICOTINE. Reason: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.. Classification: Class III. Quantity: 59,808 pouches (4,272 Individual Folding Carton (IFC)). Distribution: Nationwide within the U.S

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot #: 56841
Expires: 03/2028
UPC Codes
0536-5894
0536-5896
0536-5895
+8 more
Affected States
ALL
Report Date
June 3, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE