Rugby nicotine patches exceed impurity specifications during stability testing
Nicotine Transdermal System Patches, 14 mg, distributed by Rugby Laboratories are being recalled after elevated oxidative-related impurities exceeded shelf-life specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall for out-of-specification impurities, which the rubric places in the 1-2 band; a product-quality failure rather than a cosmetic issue puts it at Moderate.
Plain-English summary
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, made by Aveva and distributed by Rugby Laboratories of Indianapolis, NDC 0536-5895-88, is being recalled. The action covers 59,808 pouches, or 4,272 individual folding cartons.
The stated reason is failed impurities and degradation specifications: elevated levels of oxidative-related impurities exceeding shelf-life specifications during stability testing of individual units. The FDA classified the action as Class III, its least serious classification, which is applied where use of the product is not likely to cause adverse health consequences.
The affected lot is 56841, expiry 03/2028. Distribution was nationwide within the United States.
Consumers who have the affected lot should stop using it and contact the retailer or pharmacy where it was purchased. Anyone with concerns about stopping a nicotine replacement course should speak to a healthcare professional.
The recalled product
- Product
- NICOTINE (NICOTINE)
- Brand
- NICOTINE
- Manufacturer
- AVEVA Drug Delivery Systems, Inc.
- Category
- Drug — Transdermal patch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 56841
- Expires: 03/2028
Distribution
Distributed nationwide across the United States.
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