Reported Jun 3, 2026 · Ongoing
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis,…
AVEVA Drug Delivery Systems, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AVEVA Drug Delivery Systems, Inc. · 3250 Commerce Pkwy · Miramar, FL · 33025-3907
Is this the product you have?
- Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva
- Distributed byRUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88
- Lot codes and dates
- Lot #: 56841
- Expires03/2028
- Amount recalled
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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