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Another ETHEX Generic Drug Recall

Nov 10, 2008 | Parker Waichman Alonso LLP

Generic drug maker ETHEX Corporation has  initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs.  Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as twice the expected dosage.

This is the third time ETHEX has recalled generic drugs for this reason.  In June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.  Last month, ETHEX recalled three lots of potentially oversized Dextroamphetamine Sulfate.

According to the Food & Drug Administration (FDA), this new ETHEX recall includes the following generic medications:

• Propafenone HCl Tablets, 150 mg: 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. 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: 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. 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: 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. 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: 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. Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009
• Isosorbide Mononitrate Extended Release Tablets, 60 mg: 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. Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009
• Morphine Sulfate Extended Release Tablets, 15 mg: The 15 mg Morphine Sulfate Extended Release Tablet is a 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 with expiration dates ranging from 12/2008 to 2/2010
• Morphine Sulfate Immediate Release Tablets, 15 mg: 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. 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: 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. 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: 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. Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

According to the FDA, 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.

Consumers who have questions regarding the ETHEX generic drug recall should call their physicians or pharmacist.  They may also contact ETHEX Customer Service at 1-800-748-1472.  Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.

All of the generic drugs involved in this latest  recall were shipped prior to May 22, 2008.  ETHEX Corporation has initiated recall notifications to wholesalers and retailers who have received any inventory of the recalled product lots with instructions for returning the recalled products. The notification also includes instructions for the retailers/pharmacies to contact consumers who were dispensed these drugs for replacement of the product and/or refund.