Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, I
Summary
The FDA issued a Class III for Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by AVEVA Drug Delivery Systems, Inc.. Reason: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability te.
Details
Source
Drug Recall
External ID
D-0550-2026
Action Date
2026-06-03
Status
Ongoing
Category
drug
Product 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.
Lot/Code Info: Lot #: 56841, Expires: 03/2028
Quantity Affected: 59,808 pouches (4,272 Individual Folding Carton (IFC))
Reason for Recall
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Distribution
Nationwide within the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-14
Company
Miramar, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 66 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
AVEVA Drug Delivery Systems, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AVEVA Drug Delivery Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AVEVA Drug Delivery Systems, Inc. have FDA actions?
AVEVA Drug Delivery Systems, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0550-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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