Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, I
Manufacturer / Brand: AVEVA Drug Delivery Systems, Inc.
Reason for Recall
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Date Issued
Category
Medications
Status
voluntary
About Medications recalls
Drug recalls in the United States are overseen by the FDA's Center for Drug Evaluation and Research. They may be initiated voluntarily by the manufacturer or requested by the FDA when contamination, potency issues, or labeling errors are identified. Class I drug recalls — the most serious — involve situations where the product may cause serious injury or death. Before stopping a prescription medication due to a recall, contact your pharmacist or prescriber: for many medications, abrupt discontinuation carries its own risks. Your pharmacy can usually arrange an emergency replacement from an unaffected lot or an alternative manufacturer at no additional cost.
What to do if you're affected
- →Stop taking the medication if it matches the recalled lot number.
- →Contact your doctor or pharmacist before stopping any prescription.
- →Return the product to your pharmacy for a refund or replacement.
- →Call the manufacturer's hotline listed on the official recall notice.
Opens the official government source. Always refer to official sources for the most current information.