Why did the FDA recall three Zicam products?
The FDA (Food and Drug Administration) has issued a warning on three zinc-containing Zicam intranasal products. The Zicam recall goes into effect immediately, today, June 16, 2009, the products are being recalled due to more than 130 reports of anosmia, or loss of sense of smell after use. The three products in question 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) Zicam products have regularly been sold in pharmacies, in retail shops, as well as over the Internet. If you have these products in your home, it is imperative to stop using them immediately. According to the reports received by the FDA, many users noticed anosmia, or loss of sense of smell after using the products one time; others stated that the condition occurred after several uses. The FDA is concerned that the condition may be permanent. Sources:
The Zicam products were recalled because they may cause a permanent loss of smell.” U.S. regulators warned Matrixx Initiatives to stop selling intranasal versions of its zinc-containing Zicam cold remedy after more than 130 reports of people losing their sense of smell after using the products. The Food and Drug Administration also urged consumers to stop taking the over-the-counter products, agency officials said on a conference call with reporters on Tuesday. Sources: http://www.knx1070.
WASHINGTON (Reuters) – U.S. regulators warned Matrixx Initiatives to stop selling intranasal versions of its zinc-containing Zicam cold remedy after more than 130 reports of people losing their sense of smell after using the products. The Food and Drug Administration also urged consumers to stop taking the over-the-counter products, agency officials said on a conference call with reporters on Tuesday. Matrixx shares fell 55 percent to $8.56 on Nasdaq. The company must seek FDA approval if it wants to continue selling the Zicam zinc products that are administered through the nose, agency officials said. Company representatives did not immediately respond to requests for a comment. Matrixx has repeatedly defended the products in the past, saying there was no direct link between Zicam and loss of smell. The FDA warning applies to Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size. Sources:
