Manufacturer Recall

Multiple Medications by ETHEX Corp. Recalled - November 2008

The manufacturer of these five medications is recalling them due to the potential presence of oversized tablets. These oversized tablets may contain twice the labeled amount of the active ingredient.

• Propafenone HCI tablets (150 mg, 225 mg, and 300mg) have been recalled by its manufacturer ETHEX Corporation
• Isosorbide Mononitrate Extend Release tablets (30 mg and 60 mg) have been recalled by its manufacturer ETHEX Corporation
• Morphine Sulfate Extended Release tablets (15 mg) have been recalled by its manufacturer ETHEX Corporation
• Morphine Sulfate Immediate Release tablets (15 mg and 30 mg) have been recalled by its manufacturer ETHEX Corporation
• Dextroamphetamine Sulfate tablets (10 mg) have been recalled by its manufacturer ETHEX Corporation

If you are currently taking one or more of these medications, ask your doctor about your treatment options. You should not use any tablets that appear to be oversized. If you do have any oversized tablets, you should return them to your dispensing pharmacy or contact ETHEX Customer Service at 1-800-748-1472 or via email at customer-service@ethex.com for instructions.

If you have questions about the recall of these products from the market, please contact your pharmacist and/or doctor or call the ETHEX Customer Service number at 1-800-748-1472, Monday through Friday, 8 a.m. to 5 p.m. Central time.

ReliOn Insulin Syringes-Medical Device Recall

On November, 6, 2008, Tyco Healthcare Group LP (Covidien) and the FDA notified healthcare professionals and patients of a voluntary recall of one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently fixed hypodermic needles. These syringes are mislabeled and when used may lead to an overdose of as much as 2.5 times the intended dose. The recalled lots were distributed by Can-Am Care and sold by Wal-Mart at Wal-Mart stores and Sam's Club under the ReliOn name. Syringes were sold at participating stores from Aug. 1, 2008, until Oct. 8, 2008. Specifically, the 31 gauge, 1cc syringes labeled for use with U-100 insulin from Lot number 813900 are impacted by this recall. The manufacturer has received one adverse report related to a syringe from this product lot.

What is ReliOn?
ReliOn syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe. These syringes are to be used to administer, typically insulin, to those diagnosed with diabetes mellitus.

What should I do?
If you suspect you have the recalled product, contact Covident at 866-780-5436 for replacement instructions. You should check the syringe packaging carefully for ReliOn 31-guage, 1cc syringes labeled as 100 units for use with the U-100 insulin from the impacted Lot number. The lot number is found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe "peel-back". Wal-Mart requests that all users return the syringes to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product. You should speak with your physician or pharmacist regarding any medical concerns. You should report signs of adverse effects, specifically unexplained hypoglycemia, to your physician.

Approximately 1400 Humana members are known to have been impacted by the recall per pharmacy and/or medical billed claims. None of the claims were filled at RightSourceRx, Humana or USAA facility due to it only being distributed at Wal-Mart and Sam's Club stores. Many other members could be impacted due to syringes being sold over-the-counter without a prescription. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its Website, and sent letters to more than 16,500 customers notifying them of the recall.

To find out more
More information about the ReliOn syringe recall can be found at the following web addresses: www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html or www.relion.com/recall

Dextroamphetamine Sulfate 5 mg tablets

The manufacturer of Dextroamphetamine Sulfate, ETHEX, is recalling the medication due to the potential presence of oversized tablets. These oversized tablets may contain twice the labeled amount of the active ingredient. Only the Dextroamphetamine Sulfate 5 mg tablets lot numbers 77946, 81141, 81142 manufactured by ETHEX are being recalled.

What should I do?
If you are currently taking Dextroamphetamine Sulfate 5 mg tablets, ask your doctor about your treatment options. You should not use any Dextroamphetamine Sulfate tablets that appear to be oversized. If you do have any oversized tablets, you should return them to your dispensing pharmacy or contact ETHEX Customer Service at 1-800-321-1705 or via email at customer-service@ethex.com.
Approximately 62 Humana members have filled a prescription for Dextroamphetamine Sulfate 5 mg tablets manufactured by ETHEX within the last 120 days. None of these claims were filled at RightSourceRx, or a Humana or USAA facility.

If you have questions about the recall of this product from the market, please contact your doctor or call the ETHEX Customer Service number at 1-800-321-1705 Monday through Friday, 8 a.m. to 5 p.m. Central time.

To discuss Dextroamphetamine Sulfate and other medications you may be taking, please call
1-888-210-8622 to schedule a telephone consultation with an RxMentor pharmacist, at no additional cost to you. If you have a speech or hearing impairment and use a TTY, call 1-800-833-3301. Representatives are available Monday through Friday, 9 a.m. - 9 p.m. Eastern time, to assist you.