Update: 1/28/2009 - The U.S Food & Drug Administration in association with ETHEX Corporation has issued another nationwide recall of many products. You can view the full recall list by clicking here.
Oversized Tablets Could Result in Intake of Up to Twice The Recommended Dosage
The recalled products are as follows:
Propafenone HCl Tablets - 150 mg, 225 mg, and 300 mg
Isosorbide Mononitrate Extended Release Tablets – 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets - 15 mg
Morphine Sulfate Immediate Release Tablets - 15 mg and 30 mg
Dextroamphetamine Sulfate Tablets - 10 mg
ETHEX has announced a voluntary recall of specific lots of the above products. These lots were recalled because of the possibility that they contain oversized tablets, which could lead to an overdose.
Overdoses of any of these products could have potentially life-threatening consequences. Overdoses of Propafenone HCl can cause arrhythmias (irregular heartbeat) and low blood pressure. Overdoses of Morphine Sulfate can cause respiratory distress, (difficulty or stoppage of breathing) and low blood pressure. Overdoses of Dextroamphetamine Sulfate can cause accelerated heart rate and elevated blood pressure.
The recalled lots were shipped before May 22, 2008. ETHEX has notified wholesalers and retailers regarding this recall. If you have used any of the recalled products, you should contact your physician immediately, especially if you have experienced an adverse reaction. If you have experienced an overdose of any of these products, you are also urged to contact an attorney.
The specific lots affected by the recall are listed below:
Propafenone HCl Tablets, 150 mg:
Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011
Propafenone HCl Tablets, 225 mg:
Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011
Propafenone HCl Tablets, 300 mg:
Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011
Isosorbide Mononitrate Extended Release Tablets, 30 mg:
Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009
Isosorbide Mononitrate Extended Release Tablets, 60 mg:
Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009
Morphine Sulfate Extended Release Tablets, 15 mg:
Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010
Morphine Sulfate Immediate Release Tablets, 15 mg:
Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011
Morphine Sulfate Immediate Release Tablets, 30 mg:
Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011
Dextroamphetamine Sulfate Tablets, 10 mg: Lots:
73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011
The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “331″ with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with ”ETH” on one side and “332″ with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with “ETH” on one side and “333″ with a bisect on the reverse. The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed “E” bisecting “30″ on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed “E” bisect “60″ on one side and bisect on the other side. The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with “15″ on one side and an “E” on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a “15″ on one side and an “ETH” on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with “30″ on one side and an “ETHEX” on the reverse. 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.
Do I Have a Lawsuit?
If you or a loved one have experienced a serious side effect related to the recall of the aforementioned ETHEX manufactured drugs, you should contact us immediately. You may be entitled to compensation for your injuries and we can help. Please use the form below for a free case evaluation.
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