Ethex Lawsuits
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Ethex Corporation’s String of Drug Recalls
Starting in June of 2008, Missouri-based Ethex Corporation began a series of product recalls resulting from ongoing quality control problems in their production facilities. Two recalls in June were for lots of tablets containing morphine sulfate. In October of 2008 the company again issued a recall, this time for dextroamphetamine sulfate tablets. In both instances the recalls were due to concern over production problems that resulted in some tablets containing up to twice the labeled dosage.
The recalls continued in November of 2008 for three dosage sizes of morphine sulfate tablets, three dosages of propafenone HCI, a heart anti-arrythmia medication, and once again a dextroamphetamine sulfate tablet. In all cases, issue remained the fact that some tablets may have been produced with double dosages, or with excessive dosage due to tablet thickness. All six products were recalled in November occurred at wholesale and retail level.
An additional recall for another morphine derivative occurred in December of 2008. Also in December Mark Hemerlin CEO of Ethex’ parent company KV Pharmaceuticals since 1975, resigned his post.
In January of 2009 Ethex continued their product retrieval by issuing a wholesale level recall for at least thirty drugs in over 125 production lots that were believed to have the same quality control problem. Among them were forms of synthetic morphine, additional lots of morphine sulfate, antihypertensive medications and numerous other prescription drugs. Recalled to the retail level – clearing both distribution warehouses and retail shelves - were three doses of hydromorphone HCl tablets, an opioid medication, and metoprolol succinate tablets.
At the end of January, parent company KV Pharmaceuticals suspended manufacture of all of its products including the entire Ethex line pending resolution of the production problems that were occurring in several of their production plants and had been in some cases, uncovered by FDA investigations. In February, Ethex issued yet another recall, on this occasion retrieving vitamins manufactured for infants that "may have been manufactured under conditions that comply with the Food & Drug Administration's current Good Manufacturing Practice."
At some point in the process the U.S. Justice Department filed suit against KV and its subsidiary, because a copy of the lengthy Consent Decree signed by both parties in the U.S. District Court in Missouri is on display on the Ethex Corp website. Over the course of 2009 several liability actions have been filed against Ethex for serious adverse reactions that patients who had been prescribed one or more of these medications had as a result of overdoses caused by the oversized tablets.
