ETHEX Corporation has voluntarily recalled specific lots of five generic products that it markets. These lots may consist of oversized tablets and may contain more than the intended levels of the active ingredient. Patients taking these oversized tablets may receive as much as twice the intended dosage of these drugs.
An overdose of these active ingredients may result in serious consequences, specifically - where an overdose of Propafenone HCL is involved, patients may experience irregular heartbeats and low blood pressure; those taking higher doses of Isosorbide Mononitrate are prone to fainting and low blood pressure; a Morphine Sulphate overdose may cause the patient to experience difficulties breathing as well as low blood pressure; and finally, an overdose of Dextroamphetamine Sulfate increases the risk of rapid heart rate and high blood pressure.
The lots involved in the recall were all shipped prior to May 22, 2008 and are described as follows:
Propafenone HCl Tablets, 150 mg:
White, scored round film coated tablet with “ETH” on one side and “331” with a bisect on the reverse
Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526
Expiration dates ranging from 03/2009 to 03/2011
Propafenone HCl Tablets, 225 mg:
White, scored round film coated tablet with “ETH” on one side and “332” with a bisect on the reverse
Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657
Expiration dates ranging from 03/2009 to 02/2011
Propafenone HCl Tablets, 300 mg:
White, scored round film coated tablet with “ETH” on one side and “333” with a bisect on the reverse
Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42
Expiration dates ranging from 06/2009 to 03/2011
Isosorbide Mononitrate Extended Release Tablets, 30 mg:
Oval, reddish-pink, film coated tablet with a debossed “E” bisecting “30” on one side and a bisect on the reverse
Lots: 62355, 66423, and 68102
Expiration dates ranging from 11/2008 to 08/2009
Isosorbide Mononitrate Extended Release Tablets, 60 mg:
Oval, yellow film-coated tablet with a debossed “E” bisecting “30” on one side and a bisect on the reverse
Lots: 63466, 66034, 67351, and 67354
Expiration dates ranging from 12/2008 to 11/2009
Morphine Sulfate Extended Release Tablets, 15 mg:
Green oval tablet with “15” on one side and an “E” on the reverse
Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687
Expiration dates ranging from 12/2008 to 02/2010
Morphine Sulfate Immediate Release Tablets, 15 mg:
Brown, round tablet with a “15” one side and an “ETH” on the reverse
Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78
Expiration dates ranging from 09/2009 to 01/2011
Morphine Sulfate Immediate Release Tablets, 30 mg:
Capsule shaped brown tablet with a “30” on one side and an “ETHEX” on the reverse
Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98
Expiration dates ranging from 08/2009 to 03/2011
Dextroamphetamine Sulfate Tablets, 10 mg:
Orange, round, flat-face, bevel edge, mottled tablet with an “ETHEX” and “312” on one side and double-scored on the reverse
Lots: 73934, 75892, 77945, 81137, 86320
Expiration dates ranging from 06/2009 to 05/2011
Patients believing they may have taken the above lots should contact their physician immediately for medical advice.
If you believe that you or a loved one has suffered serious injury or death as a result of ingesting these generic drugs, contact an attorney immediately. You may be legally entitled to compensation for medical expenses, lost wages, and compensation for pain and suffering or physical impairment.
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