Triaminic Vapor Patch Recall

Important recall: Triaminic Vapor Patches

I received this important release via email the other day and want to share it with everyone:

June 19, 2006

Dear Doctor:

RE: Recall of Vapor Patch by Triaminic

I wanted to make you aware that Novartis Consumer Health announced today it has voluntarily recalled the Vapor Patch product, marketed under the Triaminic brand. Below is the press release that was distributed today.

MEDIA RELEASE • MEDIA RELEASE • MEDIA RELEASE

Novartis Consumer Health Conducts Nationwide Voluntary Recall of Triaminic®
Vapor Patch Product in U.S.

Parsippany, NJ, June 19, 2006 – Novartis Consumer Health announced today it is conducting a nationwide voluntary
recall of all Vapor Patch product marketed under the Triaminic brand due to the serious adverse health effects that
could result if the product is ingested by the child removing the patch and chewing on it.

Consumers who have Triaminic Vapor Patches should stop using them immediately. There have been multiple reported complaints received, including seizures. Novartis Consumer Health’s number one priority is the safety of the consumers who use our products and, therefore, is taking this precautionary action.

All lots are being recalled in both product lines of mentholated cherry scent and menthol scent. Triaminic Vapor Patch contains camphor, eucalyptus oil and menthol.

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.

The recall is being conducted with the knowledge of the FDA.

Triaminic 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.

The product is sold nationwide over the counter at pharmacies and retail stores.

This recall affects only the Vapor Patch. Consumers should immediately discontinue use of this product and return it to their point of purchase 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 FDAÕs 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, Rockvillle, MD 20852-9787] or fax [1-800-FDA-0178].

We have alerted all pharmacies and supermarkets where the Vapor Patches are sold and they have removed the product from the shelves. A separate communication has also been sent to the American Academy of Pediatrics to inform them of the situation.

If you or your patients have any questions, please contact Novartis Consumer and Professional Affairs Call Center at 1-800-452-0051.

Sincerely,

Dan Ollice
National Director, Professional Sales
Novartis Consumer Health Inc.

This is a popular product with many families and clearly a medical risk to small children. Developmentally, small children, especially preschoolers and toddlers, will view any sticky thing as a sticker – bandaids, vapor patches, even mail stamps. They will play with them, put them in their mouths and put them on objects and each other. That coupled with the fact that most over the counter products do not work in small children, makes any sticker-like product for children potentially dangerous – even without an official recall such as with the triaminic vapor patch.

Email Dr. Gwenn

Links for more information:
Triaminic
FDA

Image source:
Walgreens Web Site