AAFES RECALL NO.
06-020 |
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WORLDWIDE Novartis Consumer Health, in cooperation with FDA, is voluntarily recalling all lots of Triminic brand Vapor Patch products (Mentholated Cherry and menthol scents). Vapor Patch is labeled as a cough suppressant for children two (2) years of age and older. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. Multiple patches can be applied. Once applied, the patch would be within close reach for a child to remove and place in his/her mouth. The Vapor Patch is a topical cough product applied externally and not for oral consumption. These items are being recalled due to serious adverse health effects that could result if the product is ingested by the child removing the patch and chewing on it. There have been multiple reported complaints received. The reported adverse events associated with swallowing products containing camphor or eucalyptus oils can vary from minor symptoms, such as burning sensation in the mouth, headache, nausea and vomiting, to more severe reactions, such as seizures. This recall affects only the Vapor Patch. Consumer should immediately discontinue use of this product and return it to the store for a full refund or discard it. Consumers requiring more information about this recall can contact Novartis Consumer and Professional Affairs Call Center at 1-800-452-0051 or visit www.triaminic.com. Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm, by phone 1-800-FDA-1088, or by returning the postage-paid FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax 1-800-FDA-0178. Home
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