Bulletin

Acetaminophen/dichloralphenazone/isometheptene

15 October 2009

Products Affected - Description

Products in Short Supply:

Midrin (Caraco) (NDC 14508-0304-08)

Acetaminophen (325 mg) / dichloralphenazone (100 mg) / isometheptene mucate (65 mg) capsules (Amneal) (NDC 53746-0141-01)

Discontinued Products:

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

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 states that the shortage of Midrin is due to an FDA seizure of the product.

Estimated Resupply Dates

Acetaminophen / dichloralphenazone / isometheptene products are not FDA-approved and therefore cannot be AB-rated.
Epidrine from Excellium is available in 100 count bottles.
Midrin from Caraco (NDC 14508-0304-08) is on back order and the company cannot estimate a release date.
Amneal Pharmaceuticals has acetaminophen (325 mg) / dichloralphenazone (100 mg) / isometheptene mucate (65 mg) capsules in 100 count bottles on back order and the company estimates a release date of late-October, 2009.

Related Shortages

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Hydrocodone Tablets
Hydromorphone Hydrochloride Injection
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Meperidine— Resolved
Meperidine / Promethazine— No Longer Available
Methadone Hydrochloride Injection— Resolved
Methadone Hydrochloride Tablets— Resolved
Methadone Injection— Resolved
Methadone Oral Tablets and Liquid— Resolved
Morphine PCA Syringes— Resolved
Morphine Sulfate— No Longer Available
Morphine Sulfate: Extended-Release Products
Morphine Sulfate: Oral Concentrated Solution
Oxycodone Combinations Capsules and Tablets
Oxycodone Extended-Release Tablets— Resolved
Oxycodone Tablets, Capsules, and Solutions
Pentazocine / Naloxone Tablets
Remifentanil Hydrochloride— Resolved
Sufentanil Injection— Resolved

Updated

October 15, 2009; September 15, 2009; September 10, 2008; July 28, 2008; June 25, 2008; May 21, 2008; April 8, 2008; January 28, 2008; January 16, 2008; December 11, 2007; November 28, 2007; October 11, 2007; September 17, 2007; July 23, 2007; June 29 and 11, 2007; and April 17, 2007; University of Utah, Drug Information Service

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