Novartis Consumer Health conducts nationwide voluntary recall of
Triaminic Vapor Patch product in U.S.
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[JUNE 23, 2006]
N.J. -- Novartis Consumer Health announced June 19 that it is
conducting a nationwide voluntary recall of all Triaminic Vapor
Patch products, due to the serious adverse health effects that could
result if the product is ingested by a child removing the patch and
chewing on it.
Consumers who have Triaminic Vapor
Patch products should stop using them immediately. There have been
multiple reported complaints received, including seizures. Novartis
Consumer Health's No. 1 priority is the safety of the consumers who
use the products; therefore, the company is taking this
All lots are being recalled in both product
lines, 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 a 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 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 or her mouth. The Vapor Patch is a
topical cough product applied externally and not for oral
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.
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Consumers requiring more information about this recall can
contact Novartis at 1 (800) 452-0051 or visit
Any adverse reactions experienced with the use of this product
should also be reported to the FDA's MedWatch Adverse Event
Reporting program at
by calling 1 (800) FDA-1088; by returning the postage-paid FDA Form
3500, which may be downloaded via
to MedWatch, 5600 Fishers Lane, Rockvillle, MD 20852-9787; or by faxing the completed FDA form to
1 (800) FDA-0178.
Novartis is a world leader in offering medicines to protect
health, cure disease and improve well-being. The company's goal is
to discover, develop and successfully market innovative products to
treat patients, ease suffering and enhance the quality of life.
Novartis is the only company with leadership positions in both
patented and generic pharmaceuticals. Novartis is strengthening its
medicine-based portfolio, which is focused on strategic growth
platforms in innovation-driven pharmaceuticals, high-quality and
low-cost generics, and leading self-medication, over-the-counter
brands. In 2005, approximately $4.8 billion was invested in research
and development across all businesses.
Headquartered in Basel, Switzerland, Novartis Group companies
employ approximately 91,000 people and operate in 140 countries
around the world. For more information, visit
[Novartis Consumer Health