Benefits Plans - Prescription Drug Plan: Drug Plan Updates and New Drug Releases -
Ethex drug recall notice - Morphine Sulfate IR, Dextroamphetamine ER, Isosorbide ER, Propafenone

Page last updated: Tuesday, 14-Sep-2010 15:33:18 EDT

On November 7, 2008, the FDA issued a Class 1, national recall on specific lots of the Ethex products listed below. For more information see the FDA website at http://www.fda.gov/oc/po/firmrecalls/ethex11_08.html

ETHEX Drug Product Tablet Descriptive

Dextroamphetamine sulfate ER 10mg

round, flat-face, bevel edge, orange mottled tablet debossed "ETHEX" and "312" on one side and double-scored on the other side

Morphine Sulfate ER, 15mg

green oval tablet with "15" on one side and an "E" on the reverse

Morphine Sulfate IR, 15mg

round brown tablet with a "15" on one side and an "ETH" on the reverse

Morphine Sulfate IR, 30mg

capsule shaped brown tablet with "30" on one side and an "ETHEX" on the reverse

Propafenone HCI, 150mg

white, scored round film coated tablet with "ETH" on one side and "331" with a bisect on the reverse

Propafenone HCI, 225mg

white, scored round film coated tablet with "ETH" on one side and "332" with a bisect on the reverse

Propafenone HCI, 300mg

white, scored round film coated tablet with "ETH" on one side and "333" with a bisect on the reverse

Isosorbide ER, 30mg

oval, reddish-pink, film-coated tablet with a debossed "E" bisecting "30" on one side and bisect on the other side

Isosorbide ER, 60mg

oval, yellow film-coated tablet with a debossed "E" bisect "60" on one side and bisect on the other side.

The voluntary specific lot recall is due to the possibility that oversized tablets may have been commercially released. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs. Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.

If you or another person covered under your benefit plan are using one of these products discontinue use of the product immediately and contact your pharmacy to determine if you may have a recalled product. Your pharmacy will advise you of next steps. Any additional inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, 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, 8:00 am to 5:00 pm Central Standard Time (CST).

If you or another person covered under your benefit plan experience any adverse reactions to these drugs, contact your physician and/or healthcare provider immediately.

Your doctor can consult the University of Michigan Formulary or the University of Michigan Preferred Drug List on the Benefits Office website to see if there is an appropriate alternative: benefits.umich.edu/plans/drugs

Your doctor is best qualified to balance quality and safety considerations in choosing the most appropriate medications for you.  The final prescribing decision rests with you and your doctor.

If you have any questions, please contact the SXC member call center toll-free at 1-866-715-0874. Plan participants using a telecommunications device for the deaf (TDD) may call 1-800-231-4403.

Limitations
The University of Michigan in its sole discretion may modify, amend, or terminate the benefits provided with respect to any individual receiving benefits, including active employees, retirees, and their dependents. Although the university has elected to provide these benefits this year, no individual has a vested right to any of the benefits provided. Nothing in these materials gives any individual the right to continued benefits beyond the time the university modifies, amends, or terminates the benefit. Anyone seeking or accepting any of the benefits provided will be deemed to have accepted the terms of the benefits programs and the university's right to modify, amend or terminate them.