Guaifenesin Extended-Release Products

28 May 2008

Products Affected - Description

All guaifenesin extended release products, including combination products.

Reason for the Shortage

• On May 25, 2007, FDA ordered companies to stop manufacturing and marketing unapproved guaifenesin extended-release products. Many of these products are combinations of guaifenesin and either a decongestant or an antitussive. More information is available in an ASHP news story.
• Manufacturers must stop production within 90 days and stop shipping product within 180 days of today's action. Manufacturers may choose to submit an application for approval but must still comply with these timelines.
• Many manufacturers of guaifenesin extended-release products discontinued their products as a result of previous regulatory actions. In October 2002, the FDA required all manufacturers of extended-release guaifenesin-only products to either submit a New Drug Application or discontinue marketing such products.

Estimated Resupply Dates

Adams Respiratory Therapeutics is the only manufacturer with approval to market guaifenesin extended-release products. These products are available over-the-counter and include Mucinex (guaifenesin 600 mg, 1200 mg), Mucinex D (guaifenesin plus pseudoephedrine), and Mucinex DM (guaifenesin plus dextromethorphan).

Updated

May 28, 2008; May 25, 2007; March 28, 2006; University of Utah, Drug Information Service

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