D-0550-2026 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 3, 2026
- Initiation Date
- May 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Distribution Pattern
Nationwide within the U.S
Code Information
Lot #: 56841, Expires: 03/2028