ROCKVILLE, Md., Oct. 16 -- The FDA announced the recall of dextroamphetamine sulfate 5-mg tablets because they may contain as much as twice the labeled amount of active ingredient.
The voluntary recall applies to three lots of the product -- 77946, 81141, and 81142 -- shipped between January 2007 and May 2008 by ETHEX Corporation, of St. Louis, Mo.
The manufacturer found a small number of oversized tablets in lots that hadn't yet been distributed, according to a company release.
There have been no reported adverse events associated with the product, according to the FDA, and ETHEX said it had not received any report of oversized tablets from any of its wholesalers, retailers, or consumers.
Multiple companies sell versions of the generic dextroamphetamine sulfate. The tablets in question are round and orange and have "ETHEX" and "311" etched on one side.
Dextroamphetamine sulfate is a psychostimulant used primarily to treat Attention-Deficit Hyperactivity Disorder (ADHD) and narcolepsy.
A dextroamphetamine sulfate overdose may put patients at an increased risk of tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, or nausea, the FDA said.
This is the company's second recall this year because of manufacturing defects that resulted in double-strength tablets.
In June, ETHEX recalled morphine sulfate 60-mg extended release tablets because they were double the appropriate thickness and could contain a double dose of morphine, according to the FDA.
The voluntary recall applies to three lots of the product -- 77946, 81141, and 81142 -- shipped between January 2007 and May 2008 by ETHEX Corporation, of St. Louis, Mo.
The manufacturer found a small number of oversized tablets in lots that hadn't yet been distributed, according to a company release.There have been no reported adverse events associated with the product, according to the FDA, and ETHEX said it had not received any report of oversized tablets from any of its wholesalers, retailers, or consumers.
Multiple companies sell versions of the generic dextroamphetamine sulfate. The tablets in question are round and orange and have "ETHEX" and "311" etched on one side.
Dextroamphetamine sulfate is a psychostimulant used primarily to treat Attention-Deficit Hyperactivity Disorder (ADHD) and narcolepsy.
A dextroamphetamine sulfate overdose may put patients at an increased risk of tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, or nausea, the FDA said.
This is the company's second recall this year because of manufacturing defects that resulted in double-strength tablets.
In June, ETHEX recalled morphine sulfate 60-mg extended release tablets because they were double the appropriate thickness and could contain a double dose of morphine, according to the FDA.
Source : http://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/11347
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