Isosorbide Mononitrate

Ethex Recalls Specific Lots of Potentially Oversized Isosorbide Mononitrate Extended Release Tablets

November 7, 2008– ETHEX Corporation of St. Louis, MO has voluntarily recalled specific lots of Isosorbide Mononitrate Extended Release Tablets (30 and 60 mg) due to the possibility that oversized pills containing twice the appropriate dose may have been manufactured and commercially released. 

Isosorbide Mononitrate is a prescription drug known as a vasodilator, used in the treatment of heart conditions such as angina pectoris. It works by dilating the blood vessels to reduce blood pressure.  Side effects associated with an overdose of Isosorbide Mononitrate include fainting and low blood pressure.

The following lot numbers are involved in this recall:

• Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots:  62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009. The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed “E” bisecting “30” on one side and bisect on the other side.
  
• Isosorbide Mononitrate Extended Release Tablets, 60 mg:  Lots:  63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009.  The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed “E” bisect “60” on one side and bisect on the other side.
  

In addition to the recalled Propafenone HCI tablets, Ethex announced that it is also recalling specific lots of four other generic/non-branded products it manufactures due to the similar potential for oversized tablets:  Propafenone HCI Tablets, Dextroamphetamine Sulfate Tablets, Morphine Sulfate Extended Release Tablets, and Morphine Sulfate Immediate Release Tablets. An overdose of any of these drugs can have serious health consequences. The lots involved in the November 7^th recall were all shipped prior to May 22, 2008.

On December 23, 2008 Ethex announced that it had also recalled a single lot of Hydromorphone HCI 2 mg tablets due to the possibility it may contain oversized tablets. Simultaneously, KV Pharmaceutical, Ethex’s parent company, announced a voluntary suspension of all shipments of its FDA approved drugs in tablet form. 

Note - Do not change medications without first consulting your doctor.

Please fill out the form below to contact a Case Manager.