Codeine / Guaifenesin / Pseudoephedrine Liquid

23 July 2009

Products Affected - Description

Codeine / Guaifenesin / Pseudoephedrine Liquid, Qualitest
Phenylhistine Expectorant, 120 mL (NDC 00603-1521-54) - discontinued
Phenylhistine Expectorant, 480 mL (NDC 00603-1521-58) - discontinued
Cheratussin DAC (Vintage label), 480 mL (NDC 00254-9068-58) - discontinued
Codafed Expectorant (Vintage label), 480 mL (NDC 00254-9073-58) - discontinued

Codeine / Guaifenesin / Pseudoephedrine Liquid, Morton Grove

Reason for the Shortage

• Multiple manufacturers (Cypress, Major, Teva, Watson, Wyeth Consumer Health) have discontinued their codeine / guaifenesin / pseudoephedrine liquids. All codeine / guaifenesin / pseudoephedrine liquids are unapproved.
• Qualitest had temporarily discontinued their codeine / guaifenesin / pseudoephedrine liquids due to a raw material shortage of pseudoephedrine. They have permanenently discontinued all codeine / guaifenesin / pseudoephedrine liquids except for the Cheratussin DAC.

Estimated Resupply Dates

• Qualitest has available Cheratussin DAC in the 480 mL (NDC 00603-1078-58) size.
• Morton Grove has Mytussin DAC syrup available in the 118 mL (NDC 60432-0541-04) and the 473 mL (NDC 60432-0541-16) sizes.

Updated

July 23, 2009; June 30, 2009; May 11, 2009; April 1, 2009; February 26, 2009; December 19, 2008; December 12, 2008; University of Utah, Drug Information Service. Copyright 2009, University of Utah, Drug Information Service.

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