The ETHEX Corporation issued a voluntary recall of five generic products due to the possibility that oversized tablets may be found in some of the lots. Oversized tablets pose the risk of patients taking more than double the prescribed dose and associated side effects. In some cases, such side effects can be life threatening.
The drugs of concern are Propafenone HCI, Isosorbide Mononitrate, Morphine Sulfate and Dextroamphetamine Sulfate. Overdose of Propafenone HCI can lead to arrhythmias (irregular heartbeat) and low blood pressure. Isosorbide Mononitrate overdose can cause fainting and low blood pressure. Morphine Sulfate overdose may lead to respiratory depression and low blood pressure. Dextroamphetamine overdose complications can include rapid heart rate and high blood pressure.
All lots were shipped prior to May 22, 2008. The tablet and Lot number descriptions are as follows:
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.
Distributors and retailers have been notified of the recall and instructed to return the products and notify consumers. The products will be replaced or refunded. Consumers are urged to contact the ETHEX consumer inquiry number, pharmacist, or health care provider. Any adverse reactions should also be reported to the FDA.
ETHEX Customer Service: 1-800-748-1472. Fax ETHEX Customer Service at 314-646-3751 or Email: customer-service@ethex.com. Representatives available Monday through Friday, 8:00 am to 5:00 pm Central Standard Time (CST).
FDA’s MedWatch Program:1-800-FDA-1088, Fax at 1-800-FDA-0178, mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or the MedWatch website at www.fda.gov/medwatch.
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