To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Ethex Recalls 3 Lots of Dextroamphetamine Sulfate Due to Oversized Tablets URL: http://www.pslgroup.com/dg/22EFA6.htm Doctor's Guide October 17, 2008
St. Louis, Miss -- October 17, 2008 -- ETHEX Corporation has voluntarily recalled 3 specific lots (77946, 81141, and 81142) of dextroamphetamine sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. This recall is being conducted with the knowledge of the US Food and Drug Adminisration (FDA). The recalled lots were distributed by ETHEX Corporation between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with 'ETHEX' and '311' on 1 side. If someone were to take a higher than expected dose of Dextroamphetamine Sulfate, then the risk of adverse effects known to be associated with the drug such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth may be increased. No report of any oversized dextroamphetamine sulfate tablets has been received by ETHEX from any wholesaler, retailer, consumer or caregiver, and ETHEX has not received any report of unexpected side effects or injury related to this product. ETHEX Corporation is conducting this precautionary, voluntary recall because it found a small number of oversized tablets in lots which had not yet been distributed. These oversized tablets were removed before the lots were distributed. Please be aware that there are multiple companies in the United States producing and marketing generic versions of dextroamphetamine sulfate 5 mg tablets and consumers and their caregivers are encouraged to check their prescriptions to determine the source of their tablets. Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com. Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch. SOURCE: US Food and Drug Administration --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.