[26 January 2011]
Products Affected - Description
Acetaminophen (325 mg) / Dichloralphenazone (100 mg) / Isometheptene Mucate (65 mg) (Interpharm for URL) - discontinued
Acetaminophen (325 mg) / Dichloralphenazone (100 mg) / Isometheptene Mucate (65 mg) (Jerome Stevens) - discontinued
Amidrine (Actavis) - discontinued
Duradrin (Barr) - discontinued
I.D.A (Interpharm for Teva) - discontinued
Migrazone (Breckenridge) - discontinued
Migratine (Major) - discontinued
Migrin-A (Prasco) - discontinued
Migquin (Interpharm for Qualitest) - discontinued
Midrin (Caraco) (NDC 14508-0304-08) - discontinued
Acetaminophen (325 mg) / dichloralphenazone (100 mg) / isometheptene mucate (65 mg) capsules (Amneal) NDC 53746-0141-01) - discontinued
Epidrine (Excellium) NDC 61425-0101-01) - discontinued
Reason for the Shortage
- Most acetaminophen / dichloralphenazone / isometheptene products have been discontinued. The manufacturers would not provide a reason for the discontinuations; however, these products are not FDA-approved.
- Caraco has discontinued their product. Product was recently seized by US Marshals due to good manufacturing practice violations.
- Exellium has previously discontinued their Epidrine 250 count presentation. Excellium discontinued the Epidrine 100 count presentation in January, 2011.
Estimated Resupply Dates
- Acetaminophen / dichloralphenazone / isometheptene products are not FDA-approved and therefore cannot be AB-rated.
- There are no current manufacturers of acetaminophen / dichloralphenazone / isometheptene products.
January 26, 2011; December 21, 2010; November 24, 2010; October 15, 2010; September 3, 2010; August 3, 2010; January 20, 2010; December 3, 2009; October 15, 2009; September 15, 2009; September 10, 2008; July 28, 2008; June 25, 2008; April 8, 2008; March 4, 2008; January 16, 2008; December 11, 2007; November 28, 2007; October 11, 2007; September 17, 2007; July 23, 2007; June 11, 2007; April 17, 2007, University of Utah, Drug Information Service. Copyright 2011, University of Utah, Drug Information Service.
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