Posts Tagged ‘fda’

FDA warns consumers to stop using three Zicam intranasal products.

Tuesday, June 16th, 2009

On June 16, 2009, the Food and Drug Administration (FDA) warned consumers to stop using and discard three zinc-containing Zicam intranasal products. The products may cause a loss of sense of smell.

FDA’s action affects Zicam’s three intranasal products that contain zinc. 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)

The FDA said they received more than 130 reports of anosmia—the loss of sense of smell—associated with use of above three Zicam products. Many people who experienced a loss of sense of smell say that the condition occurred with the first dose, although some people have reported loss of sense of smell after later doses. FDA is concerned that the loss of sense of smell may be permanent.