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Published on Nov 10, 2008 by Edgar Snyder

Generic Oversized Drugs Recalled

Ethex recalls

ETHEX Corporation has announced the voluntary recall five generic drugs that it markets. The affected lots may contain oversized tablets, which if taken, could result in patients receiving as much as twice the expected dosage.

The recalled drugs include Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate, all of which can have serious or life-threatening side effects. The health risks for Propafenone HCl include arrhythmias (irregular heartbeat) and low blood pressure. Risks for Isosorbide Mononitrate are fainting and low blood pressure. In the case of Morphine Sulfate, side effects can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, the health effects can include rapid heart rate and high blood pressure.

ETHEX Corporation has issued recall notifications to wholesalers and retailers who have received any inventory of the recalled lots. The notification also instructs retailers and pharmacies to contact consumers who were given the drugs. Consumers who experience any adverse reactions to these drugs should contact their healthcare provider immediately. A press release issued by ETHEX contains a complete list of the recalled lots.

Source: "ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets." FDA Alert. November 7, 2008.
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