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Voluntary Recall of Potentially Oversized Tablets Expanded

From the medical news site www.medpagetoday.com:

ETHEX Corporation announced the voluntary recall of lots of five generic medications because they may contain more than the labeled amount of active ingredient, the FDA said.

The recall applies to 150-, 225-, and 300-mg propafenone HCl tablets, 30- and 60-mg isosorbide mononitrate extended-release tablets, 15-mg morphine sulfate extended-release tablets, 15- and 30-mg morphine sulfate immediate-release tablets, and 10-mg dextroamphetamine sulfate tablets.

Overdoses of all four of the drugs can have serious and life-threatening complications, according to an FDA press release announcing the recall.

These include arrhythmias and low blood pressure with propafenone HCl, fainting and low blood pressure with isosorbide mononitrate, respiratory depression and low blood pressure with morphine sulfate, and rapid heart rate and high blood pressure with dextroamphetamine sulfate, the agency said.

Earlier this year, the drug maker voluntarily withdrew three lots of 5-mg dextroamphetamine sulfate tablets and 60-mg morphine sulfate extended-release tablets. (See: Dextroamphetamine Sulfate Tablets Recalled)

The following lots are involved in the current recall and were shipped before May 22:

* 150-mg propafenone HCl tablets (73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011)
* 225-mg propafenone HCl tablets (71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011)
* 300-mg propafenone HCl tablets (72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011)
* 30-mg isosorbide mononitrate extended-release tablets (62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009)
* 60-mg isosorbide mononitrate extended-release tablets (63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009)
* 15-mg morphine sulfate extended-release tablets (81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010)
* 15-mg morphine sulfate immediate-release tablets (77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011)
* 30-mg morphine sulfate immediate-release tablets (75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011)
* 10-mg dextroamphetamine sulfate tablets (73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011)

Source here.

Full post as published by A Georgia Lawyer on November 11, 2008 (boomark / email).