AVEVA Drug Delivery Systems, Inc. recalls Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis,…
- Recall date
- May 14, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0550-2026
- FDA classification
- Class III
- Brand / firm
- AVEVA Drug Delivery Systems, Inc.
- Sold / distributed
- Nationwide within the U.S
Why it was recalled
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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