Unapproved hydrocodone ordered off the market by FDA

October 1, 2007

FDA orders unapproved hydrocodone makers to cease marketing

As part of its crackdown on marketing of unapproved drugs, the FDA has ordered manufacturers of hydrocodone products that have not undergone agency review to cease further production and distribution. The action is enforceable under the agency's Compliance Policy Guide, which was published in June 2006 and highlights the risks associated with such products. The FDA said it has received reports of medication errors associated with formulary changes and similarity of names of the unapproved hydrocodone, and it is particularly concerned with the fact that some products list dosages for children as young as two years despite the fact that no hydrocodone cough suppressant has been established as safe and effective for children younger than six. Companies must cease manufacture and distribution of products currently labeled for use in children under the age of six years by Oct. 31. Any other unapproved hydrocodone-containing products must stop production by Dec. 31 and cease further shipment by March 31, 2008.

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