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ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized TabletsDate: 10/21/2008
Reason: Oversized tablets may contain as much as about twice the labeled amount of the active ingredient.
Distribution: Nationwide
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. 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. Other Food Allergies Recalls and Alerts of InterestDate: 10/21/2008 Reason: The product may contain undeclared milk protein. Distribution: Kroger stores in Alabama, Arkansas, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Texas, Virginia and West Virginia. Date: 12/11/2008 Reason: People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. Distribution: Nationwide Date: 10/21/2008 Reason: The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Distribution: Nationwide Date: 10/27/2008 Reason: People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product.
Distribution: Nationwide Date: 10/21/2008 Reason: Arnold Foods Company, Inc. is recalling BROWNBERRY brand Whole Grains BREAD 100% WHOLE WHEAT (1 LB 8 OZ) because it may contain undeclared almonds, walnuts and hazelnuts. Distribution: Nationwide Wegmans Food Markets, Inc. Issues Voluntary Recall on Wegmans Italian Classics Seasoned Tomato Sauce Date: 11/21/2008 Reason: The product is being recalled because the package may actually contain a milk ingredient which is not declared on the label. Distribution: New York, New Jersey, Pennsylvania, Virginia, and Maryland. |
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