Safety Alerts & Recalls

What does this mean?

Using Zicam Cold Remedy Nasal Gel/Nasal Swab puts you at an increased risk of loss of sense of smell. The loss of sense of smell can negatively affect a person's quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

If you use Zicam products, please review the products you currently have in your household to see any of them are the Zicam Cold Remedy Nasal Gel/Nasal Swabs involved in this alert. If you think your Zicam products are involved in the alert, please stop using them and throw them away. Please visit the FDA website for more information about how to dispose of unused medicines: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm

If you have experienced a loss of sense of smell or other problems after use of the involved Zicam products, please contact your doctor.

Warnings on Three Zicam Intranasal Zinc Products

FDA notified consumers and healthcare professionals to stop using three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies. These Zicam Nasal Gel/Nasal Swab have been associated with the loss of sense of smell that may last a long time or may be permanent. These products, marketed by Matrixx Initiatives, are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms. However, these products have not been shown to be effective in the reduction of the duration and severity of cold symptoms.

The products (listed with their size and product numbers) are: Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)

Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)

Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

This advisory does not include oral zinc tablets and lozenges taken by mouth.

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Source: FDA
Publication Date: 2009-06-16
Last Updated: 2009-12-05

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