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ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets
Date:11/7/2008

Propafenone HCl Tablets - 150 mg, 225 mg, and 300 mg

Isosorbide Mononitrate Extended Release Tablets - 30 mg and 60 mg

Morphine Sulfate Extended Release Tablets - 15 mg

Morphine Sulfate Immediate Release Tablets - 15 mg and 30 mg

Dextroamphetamine Sulfate Tablets - 10 mg

ST. LOUIS, Nov. 7 /PRNewswire/ -- ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic /non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.

Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.

The lots involved in the recall were all shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243- 45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530
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SOURCE ETHEX Corporation
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