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Unapproved Hydrocodone

In September 2007, the FDA announced that it was cracking down on the manufacturers of unapproved hydrocodone cough suppressants.   According to the FDA, there are only 9 approved hydrocodone-containing cough suppressants on the market.   Those are: TussiCaps; Tussionex Pennkinetic; Hydrocodone Compound; Mycodone Homatropine Methylbromide; Hycodan; Tussigon; and Vicodin.   All of the others have not been approved by the FDA.   

The FDA took action against unapproved hydrocodone medications because it had received reports of "medication errors associated with unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products."  The FDA ordered companies making unapproved hydrocodone drug products to stop manufacturing such products on or before December, 31, 2007, and to "cease further shipment in interstate commerce on or before March 31, 2008."

The FDA also took action against hydrocodone cough suppressants marketed for young children.   No hydrocodone medication has been approved by the FDA for children under 2.  However, there are many of these dangerous drugs on the market with labels that claim they are suitable for use in very young children. The FDA ordered companies marketing unapproved hydrocodone products that are labeled for use in children younger than 6 years of age to stop manufacturing and distributing the products by October 31, 2007.

Legal Help for Victims of Unapproved Hydrocodone Products
If you or a loved one has been injured by an unapproved hydrocodone medication, you may have valuable legal rights.  Please fill out the form at the right for a free case review by a qualified attorney.