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Recall for Oversized Narcotic Tablets

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Ethex Corporation and the FDA recently issued notice of a voluntary recall of five generic narcotic tablet products because they may be oversized and contain more than twice the intended level of the active drug ingredient. This can result in patients receiving as much as twice the expected dose of the drug which could cause serious life-threatening consequences.

According to the manufacturer’s recall notice, the involved lots were all shipped prior to May 22, 2008 and 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

Taking these oversized tablets can result in various life threatening conditions including arrhythmias (irregular heartbeat), low blood pressure, fainting, difficulty breathing, and rapid heart rate. Anyone who experience any adverse reaction to these drugs should contact their physician/health care provider immediately.

Notably, this is not the first time Ethex Corporation has had to recall tablets due to a manufacturing problem in which pills contained twice the intended dosage. In June of 2008, Ethex originally recalled a single lot of morphine pills believing that the problem was limited only to a lot of pills manufactured during the period from April 16 to April 27, 2008. Only a few days later, Ethex greatly expanded the recall to include additional lots.

For more information, please visit:

http://www.fda.gov/oc/po/firmrecalls/ethex11_08.html