Drug product
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.
D-0550-2026
Product summary
- Event
- Event 98972
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
- Official record key
drug-enforcement:D-0550-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Code information: Lot #: 56841, Expires: 03/2028
Distribution pattern: Nationwide within the U.S
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications