Isosorbide Mononitrate

Isosorbide mononitrate is a generic drug used primarily to treat attacks of angina pectoris (commonly known as angina), which is severe chest pain due to a lack of blood resulting in decreased oxygen supply of the heart muscle due to an obstruction or spasm of the heart's blood vessels. Coronary artery disease is the primary cause of angina, and is due to atherosclerosis of the cardiac arteries. Isosorbide mononitrate is in a class of drugs called nitrates. The drug dilates blood vessels so it becomes easier for the heart to pump, and alllow more oxygen to flow to the heart.

On November 7, 2008, the FDA posted a press release from ETHEX Corporation announcing the recall of its generic/non-branded Isosorbide Mononitrate tablets in the following lots:

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

These lots were recalled as a precaution, as they may contain oversized tablets, which could result in patients receiving up to twice the recommended dosage. These patients could experience some serious side effects, and even risk death. Propafenone HCI overdose side effects might include fainting and low blood pressure.

According to the ETHEX Corporation press release, "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. 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."

ETHEX Corporation sent its recall notifications to wholesalers and retailers that received inventory of the Isosorbide Mononitrate lots with the possible oversized tablets. The recall notices give instructions for retailers and pharmacies to contact consumers given this medication in order that they may either get replacement of the product or a refund.

Consumers who experience any adverse reactions to Isosorbide Mononitrate tablets listed in the lot numbers above should contact their healthcare providers immediately.

If you or a family member has taken Isosorbide Mononitrate tablets from the lot numbers above, and experienced adverse side effects or died as a result, please fill out our Case Review Form to the right on this page for a free consultation.