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
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