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December 14, 2000

Triaminic Cold Remedies Containing Phenylpropanolamine Withdrawn from the Market

Summit, NJ (SafetyAlerts) - Novartis Consumer Health Inc. has voluntarily withdrawn certain Triaminic cold remedies because they contain the decongestant, phenylpropanolamine.  Novartis has stated that this is not a mandatory recall, but a voluntary action to withdraw the products and replace them with reformulated products.

Last November, the Food and Drug Administration issued a nationwide warning against using over-the-counter drugs containing phenylpropanolamine.

The FDA stated that a recent study reported that taking phenylpropanolamine increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain phenylpropanolamine.   Click here to view the FDA warning.

The Triaminic cold remedies that have been with drawn are:
Cold & Allergy
Cold & Cough
Cough Relief
Expectorant Chest Congestion.

Novartis Consumer Health has stated that they have since reformulated these products with the decongestant pseudoephedrine.  Products containing pseudoephedrine are not affected by the withdraw.

Consumers who have purchased one of the above Triaminic products containing phenylpropanolamine should call Novartis Consumer Health at 1-800-548-3708 with the lot numbers on the box for a refund.

Notice of this product warning was sent via email to SafetyAlerts subscribers December 14, 2000.  For more information regarding the SafetyAlerts free email alert service please click here.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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