The Ethex Corporation, the Missouri-based subsidiary of the KV Pharmaceutical Company, has issued another recall of its drugs that were released in oversized forms which may cause serious injury or death. This is the company's third recall for the same issue this year.
How many recalls is TOO many?
That's what many people are asking - including patients, doctors and consumer advocate groups. Although the company is working on the recall with the U.S. Food and Drug Administration (FDA), the third recall relates to the same issue of releasing oversized tablets that may contain more medication than they should - leaving many to wonder what's going on.
Here are the details of the latest recall which affect the following drugs shipped before May 22, 2008:
- 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
Previous recalls
Ethex recalled three lots of Dextroamphetamine Sulfate 5 mg tablets in October 2008 for the same reasons. In June of 2008, the company recalled 65 lots of 30 mg and 60 mg extended release Morphine tablets which contained double the amount of the drug's active ingredient.
FDA statement
According to the FDA, the recall was issued as a precaution, due to the possibility that they may contain oversized tablets. In its press release, the FDA said:
Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs. 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.
Click here
to view the FDA's press release.
If you've been injured due to a drug, contact an attorney whose practice focuses in products liability to discuss your situation. Consultations are free, without obligation and are strictly confidential.