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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets


Lot Number 77946, 81141 and 81142 NDC #58177-311-04

 

Contact:
Ann McBride
1-800-321-1705

 

FOR IMMEDIATE RELEASE -- St. Louis, MO – October 15, 2008 – ETHEX Corporation announced today that it has voluntarily recalled three 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. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one 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 with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers nationwide who have received any inventory of the recalled lots of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact ETHEX as provided above regarding procedures for returning the recalled product. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized. If consumers have any questions about the recall, they should call the telephone number above, their physician, their pharmacist or other health care provider.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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.

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