Ethex has voluntarily recalled lots of propafenone HCl, isosorbide mononitrate, extended- and immediate-release morphine sulfate and dextroamphetamine sulfate because they may contain oversized tablets. The existence of oversized tablets could result in patients receiving twice the expected dosage of these drugs. Overdoses can lead to arrhythmias and hypotension with propafenone HCl; fainting and hypotension with isosorbide mononitrate; respiratory depression and hypotension with morphine sulfate; and rapid heart rate and hypertension with dextroamphetamine sulfate.
The tablets in this recall were all shipped prior to May 22, 2008.
For more information call (800) 748-1472 or visit www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm128537.htm.