Update: 1/28/2009 - The U.S Food & Drug Administration in association with ETHEX Corporation has issued another nationwide recall of many products. You can view the full recall list by clicking here.
In November 2008, a voluntary recall of 5 generic medications manufactured by the Ethex Corporation was issued as a precautionary measure due to the chance that tablets containing the medication were oversized and contained more of the active ingredient than intended. The products affected by the recall belonged to specific lots sold to wholesalers, pharmacies, and released to the public before the end of May 2008. Some of the patients that had taken the tablets received as much as twice of the intended dosage of the active drug and suffered overdoses that required hospitalization.
The medications recalled include Dextroamphetamine Sulfate Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Propafenone HCL Tablets. In addition to overdosing on the excessive amounts of the active drug in the tablets, consuming the tablets also resulted in the development of a number of complications specific to the medication consumed. Complications associated with an overdose of Isosorbide Mononitrate included fainting and low blood pressure, while excessive amounts of Morphine Sulfate resulted in respiratory depression. An increased dosage of Dextroamphetamine Sulfate can result in a rapid heart rate and high blood pressure.
One of the more serious complications associated with an increased dosage of Propafenone is arrhythmia, the symptoms of which include dizziness, feeling light headed, chest discomfort, and shortness of breath. The condition can be dangerous to the health of the patient and in some cases, requires heart surgery to correct. Many of the complications associated with overdoses of these medications could result in a life threatening situation requiring immediate medical intervention to preserve the health of the patient.
The lots affected by the recall from the Ethex Corporation were shipped to pharmacies and wholesalers all over the country. The notifications for the recall have been sent to these locations, along with detailed instructions for the correct method of returning the recalled products. A list of the exact lot numbers, descriptions of the tablets, and expiration dates, are available from the US Food and Drug Administration or the Ethex Corporation. The government agency is overseeing the recall of these medications and obtaining reports from the healthcare community about the number of people experiencing complications due to taking the medications. Any person that has purchased these tablets should return the medication to the pharmacy for replacement or refund.
Currently, there is no estimate available for the number of people affected by the tablets before the recall was issued. The patients that ingested the oversized tablets often had to be rushed to emergency medical facilities for the treatment of serious complications associated with overdose. Any patients that believe that they are experiencing complications after taking the medications should seek medical treatment quickly to prevent the complications from becoming a life threatening issue. An alert has been sent to the healthcare community warning them to be vigilant for the development of complications in any patients that have been prescribed these medications.
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