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Published on Jun 09, 2006 by Edgar Snyder

Manufacturers of Unapproved Medicines Get Warning

Unapproved Medicines

Manufacturers of prescription cold and allergy medicines containing the antihistamine carbinoxamine were warned by the Food and Drug Administration (FDA) to quit making these products within 90 days because they are not approved by the agency.

The only company that has FDA-approval to sell medicine containing the carbinoxamine is Mikart Inc., which has approval to sell as an oral treatment for allergies.

Unapproved brand names that contain the antihistamine include:

  • Andehist
  • Cardec
  • Histex
  • Rondec
  • Tussafed

Over 120 unapproved products contain carbinoxamin. Approved medicines have carbinoxamine as the single ingredient, and most of the unapproved products contain other substances in addition to carbinoxamine. Since 1983, 21 children under two died due to a carbinoxamine drug link.

Source: “FDA Asks Certain Drug Firms Not to Make Unapproved Products.” By Jennifer Corbett Dooren. The Wall Street Journal. June 9, 2006.
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