Recall: D-0550-2026

Class III - Minor Violations

Class IIIClassification

2026-05-14Initiated

OngoingStatus

AVEVA Drug Delivery Systems, IFirm

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.

Reason

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

Distribution

Nationwide within the U.S

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.