Dextroamphetamine

Additional Lots of Potentially Oversized Dextroamphetamine Sulfate Tablets Recalled

November 7, 2008— ETHEX Corporation of St. Louis, MO has voluntarily recalled specific lots of Dextroamphetamine Sulfate Tablets (10 mg) due to the possibility that oversized tablets containing as much as twice the labeled amount of the active ingredient may have been manufactured and commercially released. On October 15, 2008 the company issued a recall of three specific lots of its Dextroamphetamine Sulfate (5 mg) product because of the potential production of oversized tablets.

Dextroamphetime is a psychostimulant drug primarily used in the treatment of attention deficit hyperactivity disorder (ADHD). An overdose of this drug could result in dangerous, life-threatening side effects.

In addition to the recalled Dextroamphetamine Sulfate tablets, Ethex announced that it is also recalling specific lots of four other generic/non-branded products it manufactures due to the similar potential for oversized tablets: Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets and Morphine Sulfate Immediate Release Tablets. An overdose of any of these drugs can have serious health consequences. The lots involved in the November 7^th recall were all shipped prior to May 22, 2008.

On December 23, 2008 Ethex announced that it had also recalled a single lot of Hydromorphone HCI 2 mg tablets due to the possibility it may contain oversized tablets. Simultaneously, KV Pharmaceutical, Ethex’s parent company, announced a voluntary suspension of all shipments of its FDA approved drugs in tablet form.

Lot Numbers involved in the November 2008 Recall:

Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011. The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel-edge, orange mottled tablet debossed “ETHEX” and “312” on one side and double-scored on the other side.

Lot Numbers involved in the October 2008 Recall:

Dextroamphetamine Sulfate Tablets, 5 mg: Lots: 77946, 81141, and 81142. The recalled lots were distributed by E Corp. under an “ETHEX” label between January 2007 and May 2008. The 5 mg tablet is an orange round tablet with “ETHEX” on one side and “311” on the other. According to the company, this voluntary recall was prompted by the identification of a small number of oversized tablets in lots which had not yet been distributed.

Side Effects Associated with a Higher Than Expected Dose of Dextroamphetamine Sulfate:

• Tachycardia
• Hypertension
• Tremors
• Decreased appetite
• Headache
• Insomnia
• Dizziness
• Blurred vision
• Stomach upset
• Dry mouth

Note - Do not change medications without first consulting your doctor.

Please fill out the form below to contact a Case Manager.