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Ethex Corporation Recalls Three Lots of Dextroamphetamine Sulfate

Oct 16, 2008 | Parker Waichman LLP

The Ethex Corporation just announced it has voluntarily recalled three lots—77946, 81141, and 81142—NDC #58177-311-04—of Dextroamphetamine Sulfate 5 mg tablets.  The recall was initiated due to the possible presence of oversized tablets that were distributed by Ethex Corporation under an "ETHEX" label dated between January 2007 and May 2008.  The 5 mg product is an orange round tablet “debossed” with "ETHEX" and "311" on one side.

Dextroamphetamine Sulfate is an amphetamine, a central nervous system stimulant, and a Schedule II drug used in the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) and in the treatment of Narcolepsy.  The oversized tablets may contain as much as twice the labeled amount of the active ingredient, which means that if one were to take a higher-than-expected dose of Dextroamphetamine Sulfate, the risk of adverse effects known to be associated with the drug may be increased.  Such adverse events include tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth.

Ethex discovered and removed a small number of oversized tablets in lots not yet distributed; however, because there are multiple companies in the U.S. producing and marketing generic versions of Dextroamphetamine Sulfate 5 mg tablets, patients and caregivers are urged to check their prescriptions to determine the source of their tablets.  Ethex Corporation sent notifications and return instructions to wholesalers and retailers nationwide who received inventory of the recalled lots.  Patients and caregivers should not use any Dextroamphetamine Sulfate tablets that appear oversized.

This is not the first time that Ethex has had to initiate a recall such as this.  In early June, Ethex recalled its morphine sulfate tablets after receiving a report of a tablet that was twice the normal size, which meant that a larger tablet could contain twice the active ingredient, putting users at risk of morphine overdose.  At that time, Ethex recalled only a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762).  The defective tablets were distributed under an “ETHEX” label between April 16th and April 27th of 2008. The recalled product was a white oval tablet with “60″ on one side, and “E” on the reverse.  Ethex did not say why it failed to recall all of its potentially defective morphine tablets in the initial recall; however, this oversight likely put thousands of morphine users in unnecessary danger.  Finally, one week later, Ethex announced that it was expanding its morphine tablet recall to include several lots of 60 mg and 30 mg extended release tablets.

Morphine overdose is characterized by a variety of symptoms including pinpoint pupils, nausea and vomiting, weak pulse, and low blood pressure.  A person suffering from morphine overdose will also have difficulty breathing, and may exhibit shallow or labored breathing.  They may also stop breathing for short periods of time and their lips and fingertips might also turn a bluish color. If they do not receive medical attention quickly, a person who has overdosed on morphine can experience seizures, fall into a coma, and possibly die.


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