Nicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
AVEVA nicotine transdermal patches (Lot 56841) are recalled due to elevated oxidative impurities exceeding shelf-life specifications. The recall affects 59,808 pouches distributed nationwide.
What this means for you
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 with no reported illnesses, injuries, or deaths. The hazard involves a failed quality specification due to elevated chemical impurities without evidence of actual harm. Class III recalls are typically scored 1-2; this is scored 2 due to the nature of the specification failure rather than cosmetic or documentation issues.
Plain-English summary
AVEVA Drug Delivery Systems, Inc. is recalling 59,808 pouches (4,272 cartons) of Nicotine Transdermal System Patch, 14 mg, distributed by Rugby Laboratories nationwide. The product carries lot number 56841 and an expiration date of March 2028.
The recall was initiated because stability testing found elevated levels of oxidative-related impurities in individual units that exceeded the product's shelf-life specifications. This indicates the product did not meet required quality standards.
Consumers who have purchased this product should consult with their healthcare provider or pharmacist regarding their supply. Additional information is available through the FDA's drug recall portal.
The recalled product
- Product
- NICOTINE (NICOTINE)
- Brand
- NICOTINE
- Manufacturer
- AVEVA Drug Delivery Systems, Inc.
- Category
- Drug — Transdermal Patch
- Hazard
- oxidative-impurities
- degradation
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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