AVEVA Drug Delivery Systems, Inc. — Class III: Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY
AVEVA Drug Delivery Systems, Inc. initiated a Class III recall for Nicotine Transdermal System Patches (14 mg) due to elevated levels of oxidative-related impurities that exceeded shelf-life specifications during stability testing.
This recall affects AVEVA Drug Delivery Systems, Inc., its distributor Rugby Laboratories, and pharmaceutical professionals involved in the manufacture, quality control, and distribution of transdermal nicotine replacement therapies.
A Class III designation suggests the products are unlikely to cause adverse health consequences, but the failure to meet stability specifications indicates potential weaknesses in the formulation's resistance to oxidation or the established shelf-life parameters. This highlights the importance of ongoing stability monitoring for individual units to detect degradation trends that may emerge post-distribution.
QA and stability teams should evaluate current testing protocols for transdermal systems to ensure oxidative degradation pathways are adequately monitored throughout the product lifecycle. Regulatory teams should verify that shelf-life specifications remain aligned with stability data for all active lots in distribution.
Class III. Reason: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.. 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.. Firm: AVEVA Drug Delivery Systems, Inc. (Miramar FL United States). Status: Ongoing.
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